Int Ophthalmol (2014) 34:1233–1239 DOI 10.1007/s10792-014-0013-y
ORIGINAL PAPER
Comparison of efficacy of three surgical methods of conjunctival autograft fixation in the treatment of pterygium Alok Sati • Sandeep Shankar • Ashok Jha • Deepak Kalra • Sanjay Mishra • V. S. Gurunadh
Received: 28 March 2014 / Accepted: 30 October 2014 / Published online: 6 November 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Our aim primarily was to compare the recurrence rate with three techniques of conjunctival fixation (suture versus fibrin glue versus autologous in situ blood coagulum) over bare sclera following pterygium excision. Ninety eyes of 90 patients with primary pterygium were randomly divided into three groups: group I (30 eyes) underwent autografting and fixation with 8-0 vicryl sutures, group II (30 eyes) with fibrin glue and group III (30 eyes) with autologous in situ blood coagulum. The patients were reviewed on 2nd day, weeks 1 and 4, and at every 3 months till
A. Sati S. Shankar (&) A. Jha D. Kalra Dept of Ophthalmology, Command Hospital (EC), Alipore Road, Kolkata, WB 700027, India e-mail: [email protected] A. Sati e-mail: [email protected]
12 months after surgery. Rate of recurrence was similar (p = 0.585) across the three groups. Time taken for surgery for Group 1 was more as compared to group 2 (p \ 0.001) and group 3 (p \ 0.001). Also, group 2 cases took significantly more time as compared to group 3 (p \ 0.001). Postoperative patient discomfort (foreign body sensation, epiphora, pain and irritation) was more in suture-assisted autografting as compared to the other two groups. However, at some points along the time line, patient discomfort was significantly more in group III as compared to group II. Complications like graft retraction, graft displacement and cyst formation were seen in a few patients but were not statistically significant across the three groups. All three techniques were found to be useful methods and were associated with similar rate of recurrence.
D. Kalra e-mail: [email protected]
Keywords Pterygium Suture assisted autografting Fibrin glue assisted autografting Autologous insitu blood coagulum assisted autografting
S. Mishra Dept of Ophthalmology, Army Hospital (R&R), Dhaula Kuan, New Delhi 110010, India e-mail: [email protected]
Introduction
V. S. Gurunadh Dept of Ophthalmology, Armed Forces Medical College, Opposite Race Course Pune-Solapur Rd, Pune, Maharashtra 411013, India e-mail: [email protected]
Pterygium (Surfer’s eye) is a benign ocular lesion characterized by a triangular fibrovascular growth from the bulbar conjunctiva on to the cornea [1]. Surgical excision of the pterygium is the standard
A. Jha e-mail: [email protected]
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treatment, but the outcomes are compromised by postoperative recurrence. To prevent the recurrence, many techniques and methods have been developed including beta-irradiation [2], mitomycin-C [3, 4], human amniotic membrane grafting [5], and autologous conjunctival grafting [6]. However, autologous conjunctival grafting has been demonstrated by many studies to be the best method with a low recurrence rate and high safety [6–9]. Traditionally, the conjunctival autograft (CAG) is attached to the sclera by suturing; however, with the advent of tissue adhesives in the ophthalmic armamentarium, fibrin glue usage gained momentum due to several of its advantages, including shortened operating time, improved postoperative comfort, and absence of suture-related complications [10–13]. CAG using autologous in situ blood coagulum is an emerging theme in pterygium surgery in recent years. Many reports have described the successful outcomes of this newer modality [14–16]. The purpose of the current study is primarily to compare the recurrence rate besides the efficacy of the above-mentioned three techniques of conjunctival fixation over bare sclera following pterygium excision. To the best of our knowledge, no such comparative study in terms of recurrence rate has been published in the literature.
Materials and methods Ninety consecutive patients (90 eyes) with primary nasal pterygium were enrolled in this prospective study. A comprehensive medical and ocular history was obtained, including patient age, gender, medical and ocular history. A detailed ocular examination was performed preoperatively. Eyes with ocular pterygia of grade 1, 2 and 3 (Tan et al. [17] ) and at least 2-mm extension from the limbus was included in the study. Patients with ocular surface disorders, pseudopterygium, hypersensitivity to any blood components (as Tisseel is composed of blood components) and positive serology for human immunodeficiency virus and hepatitis B were excluded from the study. Informed written consent was obtained from all the patients. The study was performed following the Declaration of Helsinki and was approved by the ethical committee of the institute. Patients were randomized using linear systematic sampling into three groups: group I (30 eyes)
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underwent CAG with 8-0 vicryl suture, group II (30 eyes) underwent CAG with fibrin glue and group III (30 eyes) underwent CAG with autologous in situ blood coagulum. To ensure subjective evaluation of symptoms, the patients were masked. All the three groups were primarily compared in terms of recurrence of pterygium besides postoperative patient discomfort and duration of surgery. All surgeries were performed under peribulbar anaesthesia (2 % lidocaine) by the same surgeon (SS). The pterygium was dissected from the apex using a crescent knife. The body of the pterygium and the underlying fibrovascular tissues were delineated from the conjunctiva and removed. The dimensions of the bare sclera bed were measured with a calliper, and a free graft with an additional 1.0 mm of length and width was then obtained from the superotemporal bulbar conjunctiva with care to obtain a Tenon-free graft. The graft was then immediately transferred onto the bare sclera with correct orientation. In group I, 8/0 vicryl (Surgisilk, Sutures Ltd., Wrexham Wales, UK) sutures (8–10, interrupted) were used to suture the graft with the surrounding conjunctiva. In group II, fibrin glue was used to secure the graft. After drying the scleral bed with a cellulose sponge, one drop of glue (fibrin) was placed under the graft and another drop (thrombin) was put on the scleral bed. The conjunctival graft was placed on the scleral bed and left there for 1–2 min for drying. The fibrin glue (Tisseel VH, Baxter AG) was prepared by reconstituting freeze-dried protein concentrate and thrombin in fibrinolysis inhibitor solution and calcium chloride solution, respectively, and were warmed for 20 min in a patented fibrinotherm device. In group III, the CAG was applied over the bare area with bleeding vessels and allowed to adhere spontaneously over it after tucking under the surrounding conjunctiva. The free graft position was adjusted using a lens spatula and Mc Pherson forceps. The operating time was measured, starting from the placement of the lid retractor to its removal at the end of the surgery. Ciprofloxacin–dexamethasone ointment (Ciplox-D; Alcon Laboratories) was placed in all eyes and a pressure patch applied for 24 h. Postoperative therapy included combination therapy with (1 % prednisolone acetate eye drops and 0.3 % ofloxacin eye drops) every 6 h in the first week, followed by application of only a topical steroid in tapering dosage over a period of 1 month. The patients
Int Ophthalmol (2014) 34:1233–1239 Table 1 Patient demographics and variables in three groups
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Variables
Vicryl suture group (n = 30)
Fibrin glue group (n = 30)
Autologous insitu blood coagulum group (n = 30)
P value
Mean (SD) age, years
40.9 ± 2.73
40.1 ± 2.32
40.63 ± 2.54
0.46 0.83
Sex Female (%)
12 (40)
12 (40)
10 (33.33)
Male (%)
18 (60)
18 (60)
20 (66.67)
Pterygium grade Grade 1 (%)
6 (20)
6 (20)
6 (20)
Grade 2 (%)
16 (53.33)
16 (53.33)
16 (53.33)
Grade 3 (%)
1.00
8 (26.67)
8 (26.67)
8 (26.67)
Horizontal size of graft
3.73 ± 0.41
3.93 ± 0.5
3.85 ± 0.42
0.224
Vertical size of graft (make ingnificant)*
5.47 ± 0.41
5.62 ± 0.31
5.53 ± 0.32
0.260
Operative time (Minutes ± SD) (pair wise analaysis)*
27.63 ± 1.63
15.5 ± 1.2
16.97 ± 1.35
\0.001
were reviewed on 2nd day after surgery and then at weeks 1 and 4, and at every 3 month till 12 months. A slit-lamp examination was performed at every visit to monitor autograft integrity and development of complications such as graft retraction, graft displacement, corneal defects, granuloma formation, recurrence or any other complication. Recurrence was defined as any fibrovascular growth that passed on to the cornea across the limbus. For grading of symptoms (pain, foreign body sensation, irritation and epiphora), patients were asked to fill out a questionnaire on postoperative day 01, day 07 and day 30, using a five-point scale adapted from Lim-Bon-Siong and associates in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities [18]. Statistical analysis Continuous variables like age, horizontal and vertical size of graft, operative time and postoperative patient discomfort in the form of foreign body sensation, epiphora, pain and irritation were expressed as mean ± standard deviation and compared across the groups using one way ANOVA test. Categorical variables like gender, complications were expressed as the number of patients and percentage of patients
and compared across the groups using Pearson’s ChiSquare test for Independence of Attributes. Comparison over time was done using Paired t test. The statistical software SPSS version 16 was used for the analysis. An alpha level of 5 % was taken, i.e. if any p value was less than 0.05, it was considered as significant.
Results Preoperative characterstics (Table 1) In terms of age (p = 0.46) and gender distribution (p = 0.83), there was no significant difference across the three groups. Pterygium of grade 1, 2 and 3 were included in all the three groups (p = 1.00). Conjunctival graft size was similar across the three groups [horizontal (p = 0.224) and vertical (p = 0.260)]. Patients of all the three groups were followed for at least one year and there was no drop out because of excellent communication with the patients. Recurrence rate (Table 2) Recurrence was assessed at 1,3,6,9 and 12 months postoperatively and was seen in 3 patients in group 1 (10 %), 2 patients in group 2 (6.67 %) and 3 patients in group 3 (3.33 %). When the three groups were compared using Pearson’s Chi square Test for
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Table 2 Comparison of graft-related complication in three groups Complications
Vicryl suture group (n = 30)
Fibrin glue group (n = 30)
Autologous insitu blood coagulum group (n = 30)
P value
Recurrence
3 (10)
2 (6.67)
1 (3.33)
0.585
Graft retraction
0 (0)
1 (3.33)
3 (10)
0.160
Graft displacement
0 (0)
1 (3.33)
2 (6.67)
0.355
Cyst formation
0 (0)
0 (0)
1 (3.33)
0.364
Fig. 1 a–d Comparison of postoperative symptoms among three groups
independence of attributes, a statistically insignificant difference (p = 0.585) was observed across them. Recurrence was seen at 6 months in group 1 and group 2 whereas in group 3, it was observed at 3 months in one patient and at 6 months in the remaining two patients. Reintervention in the form of regraft was declined by all the patients except one in group 3. Other complications (Table 2) Graft retraction was seen in one patient in group 2 (3.33 %) and in 3 patients in group 3 (10 %). This retraction was in between the nasal margin of the graft and the conjunctiva. The gap was small and linear and was completely epithelised in 01 week in all patients.
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Hence, no intervention was contemplated. Graft displacement was seen in the immediate postoperative period in one patient in group 2 (3.33 %) and in two patients in group 3 (6.67 %). The displaced graft was realigned over bare sclera using the same fixative technique used in the preceding surgery. Cyst formation (Fig. 2) was seen at 3 months postoperatively in one patient in group 3 along with recurrence and was managed by excision of pterygium and cyst. Operative time As shown in Table 1, using one way ANOVA test, a statistically significant difference was seen in the operative time across the three groups (p \ 0.001). On
Int Ophthalmol (2014) 34:1233–1239
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Discussion
Fig. 2 Cyst formation and recurrent pterygium in a patient underwent conjunctival fixation with autologous insitu blood coagulum
pairwise comparison using unpaired t test, group 1 cases took more time as compared to group 2 (p \ 0.001) and group 3 (p \ 0.001). Also, group 2 cases took significantly more time as compared to group 3 (p \ 0.001). Postoperative symptoms (Fig. 1a–d) Foreign body sensation: It persisted till day 14 in group 2 and 3, whereas it lasted till day 30 in group 1. On comparing means within the group, a statistically significant improvement Fig. 2 in symptoms was seen to occur over time. Across the groups on postoperative day 1, day 7 and day 14, this symptom was significantly more in group 1 as compared to group 2 and 3. Epiphora: It persisted till day 14 in group 2 and till day 30 in groups 1 and 3. This symptom improved significantly over time in all three groups. Across the groups on postoperative day 1 and day 7, this symptom was significantly more in group 1 followed by group 3 and group 2. Pain: It persisted till day 14 in all three groups. This symptom improved significantly over time in all three groups. Similar to epiphora, this symptom was significantly more in group 1 followed by group 3 and group 2, on postoperative day 1 and 7. Irritation: It persisted up to day 30 in group 1 and day 14 in groups 2 and 3. This symptom improved significantly over time. While comparing across the groups over time, this symptom was significantly more in group 1 followed by group 3 and group 2.
The very purpose of pterygium excision is defeated by its recurrence. Recurrent pterygium is often aggressive with more severe inflammatory and fibroblastic response and may lead to thickening and irregularity of the affected tissues. Occasionally, recurrent pterygium may cause symblepharon formation and restriction of ocular motility. Of all the modalities described in literature [2–6], CAG technique is associated with least recurrence [7, 8, 10]. In recent times, CAG has been fixed to bare sclera either by sutures, fibrin glue or autologous in situ blood coagulum. Amongst the three techniques of conjunctival fixation, the technique associated with the least amount of recurrence is a matter of debate. In an endeavour to resolve this debatable issue, we carried out this prospective study primarily to compare the rate of recurrence amongst the three techniques of conjunctival fixation. In the current study, we have not found any significant difference amongst the three techniques of conjunctival fixation in terms of recurrence. Extensive MEDLINE search failed to reveal any study comparing the three techniques of conjunctival fixation. On the contrary, literature is laden with comparative analysis of two techniques especially glue versus suture-assisted autografting. The recurrence rate following aforementioned techniques is a matter of controversy. Some reports [12, 19, 20] stated an insignificant difference, whereas a few [21, 22] stated otherwise i.e. fibrin glue-assisted autografting has a lower recurrence rate compared to sutureassisted autografting. On comparing conjunctival fixation with suture and autologous blood coagulum in terms of recurrence, Chaudhary et al. [23] found no significant difference between them. In concordance with Chaudhary et al. a similar observation was made by Singh et al. [16] on comparing fibrin glue with autologous in situ blood coagulum for conjunctival autograft. Considering the above reports, some of the inferences were found to be similar to those of ours, and still others were found to be discordant with our findings. Cha et al. [24] hypothesized that less inflammation in the early postoperative stage following glueassisted autografting may be related to less chances of recurrence. However, our comparative series does not support this hypothesis as we have found a similar recurrence rate across the three groups. We believe
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that postoperative administration of topical steroids in all three techniques takes care of inflammation. Contrary to the aforementioned study’s hypothesis, we firmly believe that it is the barrier effect of CAG across the three groups that plays a crucial role in preventing recurrence. In agreement with the existing literature [11, 12], suture-assisted autografting was also noted in our study to take more time as compared to the other two techniques. In contradiction to the only existing report [16], we found that the duration of surgery was less in autologous in situ blood coagulum group compared to autografting with fibrin glue. We believe that a greater number of studies are required to conclude our findings. Similarly, in line with the existing literature [11, 23], postoperative patient discomfort (foreign body sensation, epiphora, pain and irritation) was more in suture-assisted autografting as compared to the other two groups. However, at some points in the time line, we found that patient discomfort was significantly more in the in situ blood coagulum group as compared to fibrin glue-assisted autografting. This is especially seen in the early postoperative period and may be attributed to less inflammation in the fibrin glue group. However, more similar natured studies are required to conclusively affirm our findings. In conclusion, all the three techniques of conjunctival fixation are safe and effective and are associated with similar rates of recurrence. Moreover, the use of fibrin glue or autologous in situ blood coagulum in pterygium surgery significantly reduces operative time and postoperative discomfort. Further studies with a larger population and longer follow-up period are needed to supplement this study. Ethical standards The current study has been approved by the ethics committee of the institute and has therefore been performed in accordance with the ethical standards laid down in the 1964 declaration of Helsinki and its later amendments. It is also stated that all persons gave their informed consent prior to their inclusion in the study. Conflict of interest The authors declare that they have no conflict of interest.
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References 1. Jaros PA, Deluise VP (1988) Pingueculae and pterygia. Surv Ophthalmol 33:41–49 2. Viani GA, Fonseca EC, De Fendi LI et al (2012) Conjunctival autograft alone or combined with adjuvant beta-radiation? A randomized clinical trial. Int J Radiat Oncol Biol Phys 82:507–511 3. Donnenfeld ED, Perry HD, Fromer S et al (2003) Subconjunctival mitomycin C as adjunctive therapy before pterygium excision. Ophthalmology 110:1012–1016 4. Rubinfeld RS, Pfister RR, Stein RM et al (1992) Serious complications of topical mitomycin-C after pterygium surgery. Ophthalmology 99:1647–1654 5. Yu CM, Liang WL, Huang YY et al (2011) Comparison of clinical efficacy of three surgical methods in the treatment of pterygium. Eye Sci 26:193–196 6. Kenyon KR, Wagoner MD, Hettinger ME (1985) Conjunctival autograft transplantation for advanced and recurrent pterygium. Ophthalmology 92:1461–1470 7. Chen PP, Ariyasu RG, Kaza V et al (1995) A randomized trial comparing mitomycin C and conjunctival autograft after excision of primary pterygium. Am J Ophthalmol 120:151–160 8. Prabhasawat P, Barton K, Burkett G et al (1997) Comparison of conjunctival autografts, amniotic membrane grafts, and primary closure for pterygium excision. Ophthalmology 104:974–985 9. Al Fayez MF (2002) Limbal versus conjunctival autograft transplantation for advanced and recurrent pterygium. Ophthalmology 109:1752–1755 10. Marticorena J, Rodriguez-Ares MT, Tourino R et al (2006) Pterygium surgery; conjunctival autograft using fibrin adhesive. Cornea 25:34–36 11. Uy HS, Reyes JMG, Flores JDG et al (2005) Comparison of fibrin glue and sutures for attaching conjunctival autografts after pterygium excision. Ophthalmology 112:667–671 12. Bahar I, Weinberger D, Dan G et al (2006) Pterygium surgery: fibrin glue versus vicryl sutures for conjunctival closure. Cornea 25:1168–1172 13. Koranyi G, Seregard S, Kopp ED (2005) The cut-and-paste method for primary pterygium surgery: long-term followup. Acta Ophthalmol Scand 83:298–301 14. Wit D, Athanasiadis I, Sharma A et al (2010) Sutureless and glue free conjunctival autograft in pterygium surgery: a case series. Eye 24:1474–1477 15. Malik KPS, Goel R, Gupta A et al (2012) Efficacy of sutureless and glue free limbal conjunctival autograft for primary pterygium surgery. Nepal J Ophthalmol 24:230–235 16. Singh PK, Singh S, Vyas C, Singh M (2013) Conjunctival Autografting without Fibrin Glue or Sutures for Pterygium Surgery. Cornea 32:104–107 17. Tan DT, Chee SP, Dear KB, Lim AS (1997) Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol 115:1235–1240 18. Lim-Bon-Siong R, Valluri S, Gordon M et al (1998) Efficacy and safety of the ProTek (Vifilcon A) therapeutic soft
Int Ophthalmol (2014) 34:1233–1239 contact lens after photorefractive keratectomy. Am J Ophthalmol 125:169–176 19. Cagatay HH, Gokce G, Ekinci M et al (2014) Long-term comparison of fibrin tissue glue and vicryl suture in conjunctival autografting for pterygium surgery. Postgrad Med 126:97–103 20. Hall RC, Logan AJ, Wells AP (2009) Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol 37:584–589 21. Pan HW, Zhong JX, Jing CX (2011) Comparison of fibrin glue versus suture for conjunctival autografting in pterygium surgery: a meta-analysis. Ophthalmology 118:1049– 1054
1239 22. Karalezli A, Kucukerdonmez C, Akova YA et al (2008) Fibrin glue versus sutures for conjunctival autografting in pterygium surgery: a prospective comparative study. Br J Ophthalmol 92:1206–1210 23. Choudhury S, Dutta J, Mukhopadhyay S et al (2014) Comparison of autologous in situ blood coagulum versus sutures for conjunctival autografting after pterygium excision. Int Ophthalmol 34:41–48 24. Cha DM, Kim KH, Hyuk Jin Choi HJ et al (2012) A Comparative study of the effect of fibrin glue versussutures on clinical outcome in patients undergoing pterygium excision and conjunctival autografts. Korean J Ophthalmol 26:407–413
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ORIGINAL PAPER
Comparison of efficacy of three surgical methods of conjunctival autograft fixation in the treatment of pterygium Alok Sati • Sandeep Shankar • Ashok Jha • Deepak Kalra • Sanjay Mishra • V. S. Gurunadh
Received: 28 March 2014 / Accepted: 30 October 2014 / Published online: 6 November 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Our aim primarily was to compare the recurrence rate with three techniques of conjunctival fixation (suture versus fibrin glue versus autologous in situ blood coagulum) over bare sclera following pterygium excision. Ninety eyes of 90 patients with primary pterygium were randomly divided into three groups: group I (30 eyes) underwent autografting and fixation with 8-0 vicryl sutures, group II (30 eyes) with fibrin glue and group III (30 eyes) with autologous in situ blood coagulum. The patients were reviewed on 2nd day, weeks 1 and 4, and at every 3 months till
A. Sati S. Shankar (&) A. Jha D. Kalra Dept of Ophthalmology, Command Hospital (EC), Alipore Road, Kolkata, WB 700027, India e-mail: [email protected] A. Sati e-mail: [email protected]
12 months after surgery. Rate of recurrence was similar (p = 0.585) across the three groups. Time taken for surgery for Group 1 was more as compared to group 2 (p \ 0.001) and group 3 (p \ 0.001). Also, group 2 cases took significantly more time as compared to group 3 (p \ 0.001). Postoperative patient discomfort (foreign body sensation, epiphora, pain and irritation) was more in suture-assisted autografting as compared to the other two groups. However, at some points along the time line, patient discomfort was significantly more in group III as compared to group II. Complications like graft retraction, graft displacement and cyst formation were seen in a few patients but were not statistically significant across the three groups. All three techniques were found to be useful methods and were associated with similar rate of recurrence.
D. Kalra e-mail: [email protected]
Keywords Pterygium Suture assisted autografting Fibrin glue assisted autografting Autologous insitu blood coagulum assisted autografting
S. Mishra Dept of Ophthalmology, Army Hospital (R&R), Dhaula Kuan, New Delhi 110010, India e-mail: [email protected]
Introduction
V. S. Gurunadh Dept of Ophthalmology, Armed Forces Medical College, Opposite Race Course Pune-Solapur Rd, Pune, Maharashtra 411013, India e-mail: [email protected]
Pterygium (Surfer’s eye) is a benign ocular lesion characterized by a triangular fibrovascular growth from the bulbar conjunctiva on to the cornea [1]. Surgical excision of the pterygium is the standard
A. Jha e-mail: [email protected]
123
1234
treatment, but the outcomes are compromised by postoperative recurrence. To prevent the recurrence, many techniques and methods have been developed including beta-irradiation [2], mitomycin-C [3, 4], human amniotic membrane grafting [5], and autologous conjunctival grafting [6]. However, autologous conjunctival grafting has been demonstrated by many studies to be the best method with a low recurrence rate and high safety [6–9]. Traditionally, the conjunctival autograft (CAG) is attached to the sclera by suturing; however, with the advent of tissue adhesives in the ophthalmic armamentarium, fibrin glue usage gained momentum due to several of its advantages, including shortened operating time, improved postoperative comfort, and absence of suture-related complications [10–13]. CAG using autologous in situ blood coagulum is an emerging theme in pterygium surgery in recent years. Many reports have described the successful outcomes of this newer modality [14–16]. The purpose of the current study is primarily to compare the recurrence rate besides the efficacy of the above-mentioned three techniques of conjunctival fixation over bare sclera following pterygium excision. To the best of our knowledge, no such comparative study in terms of recurrence rate has been published in the literature.
Materials and methods Ninety consecutive patients (90 eyes) with primary nasal pterygium were enrolled in this prospective study. A comprehensive medical and ocular history was obtained, including patient age, gender, medical and ocular history. A detailed ocular examination was performed preoperatively. Eyes with ocular pterygia of grade 1, 2 and 3 (Tan et al. [17] ) and at least 2-mm extension from the limbus was included in the study. Patients with ocular surface disorders, pseudopterygium, hypersensitivity to any blood components (as Tisseel is composed of blood components) and positive serology for human immunodeficiency virus and hepatitis B were excluded from the study. Informed written consent was obtained from all the patients. The study was performed following the Declaration of Helsinki and was approved by the ethical committee of the institute. Patients were randomized using linear systematic sampling into three groups: group I (30 eyes)
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underwent CAG with 8-0 vicryl suture, group II (30 eyes) underwent CAG with fibrin glue and group III (30 eyes) underwent CAG with autologous in situ blood coagulum. To ensure subjective evaluation of symptoms, the patients were masked. All the three groups were primarily compared in terms of recurrence of pterygium besides postoperative patient discomfort and duration of surgery. All surgeries were performed under peribulbar anaesthesia (2 % lidocaine) by the same surgeon (SS). The pterygium was dissected from the apex using a crescent knife. The body of the pterygium and the underlying fibrovascular tissues were delineated from the conjunctiva and removed. The dimensions of the bare sclera bed were measured with a calliper, and a free graft with an additional 1.0 mm of length and width was then obtained from the superotemporal bulbar conjunctiva with care to obtain a Tenon-free graft. The graft was then immediately transferred onto the bare sclera with correct orientation. In group I, 8/0 vicryl (Surgisilk, Sutures Ltd., Wrexham Wales, UK) sutures (8–10, interrupted) were used to suture the graft with the surrounding conjunctiva. In group II, fibrin glue was used to secure the graft. After drying the scleral bed with a cellulose sponge, one drop of glue (fibrin) was placed under the graft and another drop (thrombin) was put on the scleral bed. The conjunctival graft was placed on the scleral bed and left there for 1–2 min for drying. The fibrin glue (Tisseel VH, Baxter AG) was prepared by reconstituting freeze-dried protein concentrate and thrombin in fibrinolysis inhibitor solution and calcium chloride solution, respectively, and were warmed for 20 min in a patented fibrinotherm device. In group III, the CAG was applied over the bare area with bleeding vessels and allowed to adhere spontaneously over it after tucking under the surrounding conjunctiva. The free graft position was adjusted using a lens spatula and Mc Pherson forceps. The operating time was measured, starting from the placement of the lid retractor to its removal at the end of the surgery. Ciprofloxacin–dexamethasone ointment (Ciplox-D; Alcon Laboratories) was placed in all eyes and a pressure patch applied for 24 h. Postoperative therapy included combination therapy with (1 % prednisolone acetate eye drops and 0.3 % ofloxacin eye drops) every 6 h in the first week, followed by application of only a topical steroid in tapering dosage over a period of 1 month. The patients
Int Ophthalmol (2014) 34:1233–1239 Table 1 Patient demographics and variables in three groups
1235
Variables
Vicryl suture group (n = 30)
Fibrin glue group (n = 30)
Autologous insitu blood coagulum group (n = 30)
P value
Mean (SD) age, years
40.9 ± 2.73
40.1 ± 2.32
40.63 ± 2.54
0.46 0.83
Sex Female (%)
12 (40)
12 (40)
10 (33.33)
Male (%)
18 (60)
18 (60)
20 (66.67)
Pterygium grade Grade 1 (%)
6 (20)
6 (20)
6 (20)
Grade 2 (%)
16 (53.33)
16 (53.33)
16 (53.33)
Grade 3 (%)
1.00
8 (26.67)
8 (26.67)
8 (26.67)
Horizontal size of graft
3.73 ± 0.41
3.93 ± 0.5
3.85 ± 0.42
0.224
Vertical size of graft (make ingnificant)*
5.47 ± 0.41
5.62 ± 0.31
5.53 ± 0.32
0.260
Operative time (Minutes ± SD) (pair wise analaysis)*
27.63 ± 1.63
15.5 ± 1.2
16.97 ± 1.35
\0.001
were reviewed on 2nd day after surgery and then at weeks 1 and 4, and at every 3 month till 12 months. A slit-lamp examination was performed at every visit to monitor autograft integrity and development of complications such as graft retraction, graft displacement, corneal defects, granuloma formation, recurrence or any other complication. Recurrence was defined as any fibrovascular growth that passed on to the cornea across the limbus. For grading of symptoms (pain, foreign body sensation, irritation and epiphora), patients were asked to fill out a questionnaire on postoperative day 01, day 07 and day 30, using a five-point scale adapted from Lim-Bon-Siong and associates in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities [18]. Statistical analysis Continuous variables like age, horizontal and vertical size of graft, operative time and postoperative patient discomfort in the form of foreign body sensation, epiphora, pain and irritation were expressed as mean ± standard deviation and compared across the groups using one way ANOVA test. Categorical variables like gender, complications were expressed as the number of patients and percentage of patients
and compared across the groups using Pearson’s ChiSquare test for Independence of Attributes. Comparison over time was done using Paired t test. The statistical software SPSS version 16 was used for the analysis. An alpha level of 5 % was taken, i.e. if any p value was less than 0.05, it was considered as significant.
Results Preoperative characterstics (Table 1) In terms of age (p = 0.46) and gender distribution (p = 0.83), there was no significant difference across the three groups. Pterygium of grade 1, 2 and 3 were included in all the three groups (p = 1.00). Conjunctival graft size was similar across the three groups [horizontal (p = 0.224) and vertical (p = 0.260)]. Patients of all the three groups were followed for at least one year and there was no drop out because of excellent communication with the patients. Recurrence rate (Table 2) Recurrence was assessed at 1,3,6,9 and 12 months postoperatively and was seen in 3 patients in group 1 (10 %), 2 patients in group 2 (6.67 %) and 3 patients in group 3 (3.33 %). When the three groups were compared using Pearson’s Chi square Test for
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Table 2 Comparison of graft-related complication in three groups Complications
Vicryl suture group (n = 30)
Fibrin glue group (n = 30)
Autologous insitu blood coagulum group (n = 30)
P value
Recurrence
3 (10)
2 (6.67)
1 (3.33)
0.585
Graft retraction
0 (0)
1 (3.33)
3 (10)
0.160
Graft displacement
0 (0)
1 (3.33)
2 (6.67)
0.355
Cyst formation
0 (0)
0 (0)
1 (3.33)
0.364
Fig. 1 a–d Comparison of postoperative symptoms among three groups
independence of attributes, a statistically insignificant difference (p = 0.585) was observed across them. Recurrence was seen at 6 months in group 1 and group 2 whereas in group 3, it was observed at 3 months in one patient and at 6 months in the remaining two patients. Reintervention in the form of regraft was declined by all the patients except one in group 3. Other complications (Table 2) Graft retraction was seen in one patient in group 2 (3.33 %) and in 3 patients in group 3 (10 %). This retraction was in between the nasal margin of the graft and the conjunctiva. The gap was small and linear and was completely epithelised in 01 week in all patients.
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Hence, no intervention was contemplated. Graft displacement was seen in the immediate postoperative period in one patient in group 2 (3.33 %) and in two patients in group 3 (6.67 %). The displaced graft was realigned over bare sclera using the same fixative technique used in the preceding surgery. Cyst formation (Fig. 2) was seen at 3 months postoperatively in one patient in group 3 along with recurrence and was managed by excision of pterygium and cyst. Operative time As shown in Table 1, using one way ANOVA test, a statistically significant difference was seen in the operative time across the three groups (p \ 0.001). On
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Discussion
Fig. 2 Cyst formation and recurrent pterygium in a patient underwent conjunctival fixation with autologous insitu blood coagulum
pairwise comparison using unpaired t test, group 1 cases took more time as compared to group 2 (p \ 0.001) and group 3 (p \ 0.001). Also, group 2 cases took significantly more time as compared to group 3 (p \ 0.001). Postoperative symptoms (Fig. 1a–d) Foreign body sensation: It persisted till day 14 in group 2 and 3, whereas it lasted till day 30 in group 1. On comparing means within the group, a statistically significant improvement Fig. 2 in symptoms was seen to occur over time. Across the groups on postoperative day 1, day 7 and day 14, this symptom was significantly more in group 1 as compared to group 2 and 3. Epiphora: It persisted till day 14 in group 2 and till day 30 in groups 1 and 3. This symptom improved significantly over time in all three groups. Across the groups on postoperative day 1 and day 7, this symptom was significantly more in group 1 followed by group 3 and group 2. Pain: It persisted till day 14 in all three groups. This symptom improved significantly over time in all three groups. Similar to epiphora, this symptom was significantly more in group 1 followed by group 3 and group 2, on postoperative day 1 and 7. Irritation: It persisted up to day 30 in group 1 and day 14 in groups 2 and 3. This symptom improved significantly over time. While comparing across the groups over time, this symptom was significantly more in group 1 followed by group 3 and group 2.
The very purpose of pterygium excision is defeated by its recurrence. Recurrent pterygium is often aggressive with more severe inflammatory and fibroblastic response and may lead to thickening and irregularity of the affected tissues. Occasionally, recurrent pterygium may cause symblepharon formation and restriction of ocular motility. Of all the modalities described in literature [2–6], CAG technique is associated with least recurrence [7, 8, 10]. In recent times, CAG has been fixed to bare sclera either by sutures, fibrin glue or autologous in situ blood coagulum. Amongst the three techniques of conjunctival fixation, the technique associated with the least amount of recurrence is a matter of debate. In an endeavour to resolve this debatable issue, we carried out this prospective study primarily to compare the rate of recurrence amongst the three techniques of conjunctival fixation. In the current study, we have not found any significant difference amongst the three techniques of conjunctival fixation in terms of recurrence. Extensive MEDLINE search failed to reveal any study comparing the three techniques of conjunctival fixation. On the contrary, literature is laden with comparative analysis of two techniques especially glue versus suture-assisted autografting. The recurrence rate following aforementioned techniques is a matter of controversy. Some reports [12, 19, 20] stated an insignificant difference, whereas a few [21, 22] stated otherwise i.e. fibrin glue-assisted autografting has a lower recurrence rate compared to sutureassisted autografting. On comparing conjunctival fixation with suture and autologous blood coagulum in terms of recurrence, Chaudhary et al. [23] found no significant difference between them. In concordance with Chaudhary et al. a similar observation was made by Singh et al. [16] on comparing fibrin glue with autologous in situ blood coagulum for conjunctival autograft. Considering the above reports, some of the inferences were found to be similar to those of ours, and still others were found to be discordant with our findings. Cha et al. [24] hypothesized that less inflammation in the early postoperative stage following glueassisted autografting may be related to less chances of recurrence. However, our comparative series does not support this hypothesis as we have found a similar recurrence rate across the three groups. We believe
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that postoperative administration of topical steroids in all three techniques takes care of inflammation. Contrary to the aforementioned study’s hypothesis, we firmly believe that it is the barrier effect of CAG across the three groups that plays a crucial role in preventing recurrence. In agreement with the existing literature [11, 12], suture-assisted autografting was also noted in our study to take more time as compared to the other two techniques. In contradiction to the only existing report [16], we found that the duration of surgery was less in autologous in situ blood coagulum group compared to autografting with fibrin glue. We believe that a greater number of studies are required to conclude our findings. Similarly, in line with the existing literature [11, 23], postoperative patient discomfort (foreign body sensation, epiphora, pain and irritation) was more in suture-assisted autografting as compared to the other two groups. However, at some points in the time line, we found that patient discomfort was significantly more in the in situ blood coagulum group as compared to fibrin glue-assisted autografting. This is especially seen in the early postoperative period and may be attributed to less inflammation in the fibrin glue group. However, more similar natured studies are required to conclusively affirm our findings. In conclusion, all the three techniques of conjunctival fixation are safe and effective and are associated with similar rates of recurrence. Moreover, the use of fibrin glue or autologous in situ blood coagulum in pterygium surgery significantly reduces operative time and postoperative discomfort. Further studies with a larger population and longer follow-up period are needed to supplement this study. Ethical standards The current study has been approved by the ethics committee of the institute and has therefore been performed in accordance with the ethical standards laid down in the 1964 declaration of Helsinki and its later amendments. It is also stated that all persons gave their informed consent prior to their inclusion in the study. Conflict of interest The authors declare that they have no conflict of interest.
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