ORIGINAL STUDY
Needle Bleb Revision With Bevacizumab and Mitomycin C Compared With Mitomycin C Alone for Failing Filtration Blebs Tak Yee Tania Tai, MD,* Marlene R. Moster, MD,w Michael J. Pro, MD,w Jonathan S. Myers, MD,w and L. Jay Katz, MDw
Purpose: To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C (MMC) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs. Methods: Patients undergoing bleb needle revision procedures were enrolled in this study. All patients received a subconjunctival injection of 0.1 mL MMC (0.4 mg/mL) mixed with 0.1 mL preservative-free lidocaine (1%) at the beginning of the procedure. The patients were randomized into 2 cohorts assigned to receive either 1.0 mg (0.04 mL of 25 mg/mL) subconjunctival bevacizumab (treatment group) or 0.04 mL of balanced salt solution (control group) injected in an identical manner posterior to the bleb after the bleb needling. Success was defined as Z20% reduction in intraocular pressure (IOP) without any IOP-lowering medications. Qualified success was defined as Z20% reduction of IOP with IOP-lowering medications. Failure was defined as IOP > 21 mm Hg, IOP reduction 21 mm Hg, IOP reduction 18 mm Hg (instead of 21 mm Hg), IOP reduction 2 lines on the Snellen chart were noted during the course of this study in both groups (Table 7). TABLE 5. Indiana Bleb Appearance Grading Scale (IBAGS) Outcomes
Evaluable Subjects (N = 58)
IBAGS
Treatment Group N = 29
Control Group N = 29
Height (on a scale of 0-3), Mean (range) Week 2 1.79 (1-3) 1.89 (1-3) Month 1 1.93 (1-3) 1.68 (0-3) Month 3 2.12 (1-3) 1.84 (1-3) Month 6 2.25 (1-3) 1.96 (1-3) Vascularity (on a scale of 0-4), Mean (range) Week 2 2.14 (1-4) 2.54 (1-4) Month 1 1.54 (0-4) 1.68 (0-3) Month 3 1.23 (0-3) 1.32 (0-3) Month 6 0.76 (0-2) 1.20 (0-3) Extent (on a scale of 0-3),* Mean (range) Week 2 2.36 (1-3) 2.37 (1-3) Month 1 2.46 (1-3) 2.07 (1-3) Month 3 2.54 (1-3) 2.12 (1-3) Month 6 2.68 (2-3) 2.36 (0-3)
P 0.56 0.30 0.24 0.32 0.11 0.72 0.49 < 0.05 0.96 0.060 0.015 0.022
Height, extent, vascularity: repeated measured analysis of covariance, with baseline as covariate. All patients were Seidel negative. *Data transformed by taking square root.
2013 Wolters Kluwer Health, Inc. All rights reserved.
www.glaucomajournal.com |
313
Tai et al
J Glaucoma
Volume 24, Number 4, April/May 2015
TABLE 6. Indiana Bleb Appearance Grading Scale (IBAGS) Outcomes (Complete Success Vs. Failure)
IBAGS
Day
Complete Success
Height (on a scale of 0-3), Mean (range) Week 2 Month 1 Month 3 Month 6 Vascularity (on a scale of 0-4), Mean (range) Week 2 Month 1 Month 3 Month 6 Extent (on a scale of 0-3),* Mean (range) Week 2 Month 1 Month 3 Month 6
Qualified Success
Failure
P
1.93 2.03 2.00 2.30
(1-3) (1-3) (1-3) (1-3)
2 1 2 (1-3) 2 (1-3)
1.54 1.50 1.95 1.85
(1-3) (0-3) (1-3) (1-3)
0.13 0.003 0.76 0.074
2.29 1.33 1.17 0.71
(1-4) (0-3) (0-3) (0-2)
2 3 1 (0-2) 2 (2-2)
2.55 1.95 1.47 1.25
(2-4) (0-4) (0-3) (0-3)
0.31 0.027 0.12 0.021
2.46 2.39 2.47 2.79
(1-3) (1-3) (1-3) (2-3)
2 1 2 (1-3) 1.5 (1-2)
2.08 2.14 2.16 2.25
(1-3) (1-3) (1-3) (0-3)
0.21 0.16 0.14 0.005
Height, extent, vascularity: comparing complete success to failure: repeated measured analysis of covariance, with baseline as covariate. *Data transformed by taking square root.
DISCUSSION Failure of the filtration bleb due to subconjunctival scar formation can be a significant problem to achieving a satisfactory IOP control after trabeculectomy. Bleb needling provides a relatively simple approach to the problem that can often lead to success in IOP control.13 Direct comparison of studies regarding the use of MMC in needling is difficult if not impossible, given the different demographics, severity of glaucoma, and timing of the needling procedure; the varying quantity, concentration, and application of the MMC; the assortment of surgical techniques, needling instruments (25, 27, 28, and 30 G needles, sharp blades), and the aggressiveness of dissection of the subconjunctival fibrosis and internal ostium, either at the slit lamp or in the operating room. The definition of success we chose is similar to that of the Tube versus Trabeculectomy study14 and is most similar to the bleb needling studies of Jacobs et al15 and Rotchford and King.13 Jacobs and colleagues performed a retrospective chart review of patients undergoing needling TABLE 7. Adverse Events
Treatment Control Group Group Hyphema Shallow anterior chamber Shallow anterior chamber necessitating injection of viscoelastic* Endothelial folds Retinal/choroidal foldsw Choroidalsw Decrease in visual acuity >2 lines on Snellen chart at 6 mo Intraocular pressure 18 mm Hg (instead of 21 mm Hg), IOP reduction 4 mm Hg,
Needle Bleb Revision With Bevacizumab and Mitomycin C Compared With Mitomycin C Alone for Failing Filtration Blebs Tak Yee Tania Tai, MD,* Marlene R. Moster, MD,w Michael J. Pro, MD,w Jonathan S. Myers, MD,w and L. Jay Katz, MDw
Purpose: To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C (MMC) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs. Methods: Patients undergoing bleb needle revision procedures were enrolled in this study. All patients received a subconjunctival injection of 0.1 mL MMC (0.4 mg/mL) mixed with 0.1 mL preservative-free lidocaine (1%) at the beginning of the procedure. The patients were randomized into 2 cohorts assigned to receive either 1.0 mg (0.04 mL of 25 mg/mL) subconjunctival bevacizumab (treatment group) or 0.04 mL of balanced salt solution (control group) injected in an identical manner posterior to the bleb after the bleb needling. Success was defined as Z20% reduction in intraocular pressure (IOP) without any IOP-lowering medications. Qualified success was defined as Z20% reduction of IOP with IOP-lowering medications. Failure was defined as IOP > 21 mm Hg, IOP reduction 21 mm Hg, IOP reduction 18 mm Hg (instead of 21 mm Hg), IOP reduction 2 lines on the Snellen chart were noted during the course of this study in both groups (Table 7). TABLE 5. Indiana Bleb Appearance Grading Scale (IBAGS) Outcomes
Evaluable Subjects (N = 58)
IBAGS
Treatment Group N = 29
Control Group N = 29
Height (on a scale of 0-3), Mean (range) Week 2 1.79 (1-3) 1.89 (1-3) Month 1 1.93 (1-3) 1.68 (0-3) Month 3 2.12 (1-3) 1.84 (1-3) Month 6 2.25 (1-3) 1.96 (1-3) Vascularity (on a scale of 0-4), Mean (range) Week 2 2.14 (1-4) 2.54 (1-4) Month 1 1.54 (0-4) 1.68 (0-3) Month 3 1.23 (0-3) 1.32 (0-3) Month 6 0.76 (0-2) 1.20 (0-3) Extent (on a scale of 0-3),* Mean (range) Week 2 2.36 (1-3) 2.37 (1-3) Month 1 2.46 (1-3) 2.07 (1-3) Month 3 2.54 (1-3) 2.12 (1-3) Month 6 2.68 (2-3) 2.36 (0-3)
P 0.56 0.30 0.24 0.32 0.11 0.72 0.49 < 0.05 0.96 0.060 0.015 0.022
Height, extent, vascularity: repeated measured analysis of covariance, with baseline as covariate. All patients were Seidel negative. *Data transformed by taking square root.
2013 Wolters Kluwer Health, Inc. All rights reserved.
www.glaucomajournal.com |
313
Tai et al
J Glaucoma
Volume 24, Number 4, April/May 2015
TABLE 6. Indiana Bleb Appearance Grading Scale (IBAGS) Outcomes (Complete Success Vs. Failure)
IBAGS
Day
Complete Success
Height (on a scale of 0-3), Mean (range) Week 2 Month 1 Month 3 Month 6 Vascularity (on a scale of 0-4), Mean (range) Week 2 Month 1 Month 3 Month 6 Extent (on a scale of 0-3),* Mean (range) Week 2 Month 1 Month 3 Month 6
Qualified Success
Failure
P
1.93 2.03 2.00 2.30
(1-3) (1-3) (1-3) (1-3)
2 1 2 (1-3) 2 (1-3)
1.54 1.50 1.95 1.85
(1-3) (0-3) (1-3) (1-3)
0.13 0.003 0.76 0.074
2.29 1.33 1.17 0.71
(1-4) (0-3) (0-3) (0-2)
2 3 1 (0-2) 2 (2-2)
2.55 1.95 1.47 1.25
(2-4) (0-4) (0-3) (0-3)
0.31 0.027 0.12 0.021
2.46 2.39 2.47 2.79
(1-3) (1-3) (1-3) (2-3)
2 1 2 (1-3) 1.5 (1-2)
2.08 2.14 2.16 2.25
(1-3) (1-3) (1-3) (0-3)
0.21 0.16 0.14 0.005
Height, extent, vascularity: comparing complete success to failure: repeated measured analysis of covariance, with baseline as covariate. *Data transformed by taking square root.
DISCUSSION Failure of the filtration bleb due to subconjunctival scar formation can be a significant problem to achieving a satisfactory IOP control after trabeculectomy. Bleb needling provides a relatively simple approach to the problem that can often lead to success in IOP control.13 Direct comparison of studies regarding the use of MMC in needling is difficult if not impossible, given the different demographics, severity of glaucoma, and timing of the needling procedure; the varying quantity, concentration, and application of the MMC; the assortment of surgical techniques, needling instruments (25, 27, 28, and 30 G needles, sharp blades), and the aggressiveness of dissection of the subconjunctival fibrosis and internal ostium, either at the slit lamp or in the operating room. The definition of success we chose is similar to that of the Tube versus Trabeculectomy study14 and is most similar to the bleb needling studies of Jacobs et al15 and Rotchford and King.13 Jacobs and colleagues performed a retrospective chart review of patients undergoing needling TABLE 7. Adverse Events
Treatment Control Group Group Hyphema Shallow anterior chamber Shallow anterior chamber necessitating injection of viscoelastic* Endothelial folds Retinal/choroidal foldsw Choroidalsw Decrease in visual acuity >2 lines on Snellen chart at 6 mo Intraocular pressure 18 mm Hg (instead of 21 mm Hg), IOP reduction 4 mm Hg,
