Intraocular Pressure
Response
Topically Administered Robert H.
Stewart, MD, Richard L. Kimbrough,
\s=b\Certain corticosteroids, including fluorometholone, have been reported to have a low propensity for elevating intraocular pressure. Our clinical impression that the incidence of IOP increase with fluorometholone may be higher than reported. This study was to determine the incidence and degree of IOP response to 0.1% fluorometholone suspension in 43 patients demonstrated to be responsive to 0.1% dexamethasone sodium phosphate solution. Twenty-six patients (60.5%) had IOP increases of 5 mm Hg or more while receiving fluorometholone, and three patients (7%) demonstrated pressure rises greater than 15 mm Hg. Fluorometholone can significantly raise IOP in a significant number of corticosteroid responders. was
(Arch Ophthalmol 97:2139-2140, 1979)
Tt has been documented that topical-
ly administered corticosteroids can produce a transient rise in intraocular pressure in a select population.1·2 Podos et al have reported that certain corticosteroids such as medrysone and drocinonide phosphate potassium are effective ocular anti-inflammatory agents that do
not show
a
strong
tendency to elevate the IOP.1 Spaeth has reported that medrysone is a
useful steroid that does not have a propensity for increasing IOP.4 Knopf also has reported that fluorometho-
Accepted for publication March 7, 1979. From the Department of Ophthalmology and the Hermann Eye Center, Conner Glaucoma Unit, University of Texas Medical School, Houston.
Reprint requests
to Hermann
Conner Glaucoma Unit, 1203 Ross Houston, TX 77030 (Dr Stewart).
Eye Center, Sterling Ave,
to
Fluorometholone
MD
effective ocular anti-inflam¬ a low propensity for elevating IOP.5 Several clinical studies have been fluorometholone conducted with where IOP was observed. The results of most of these studies show that fluorometholone has a substantially reduced tendency to increase IOP causing a very mild or no increase in IOP.6"" These studies tend to lull the clinical ophthalmologists into assum¬ ing that these preparations can be used with relative impunity and that significant pressure elevations are uncommon. Even though one study has shown that a rise in IOP was induced in two of three corticosteroid responders following the topical appli¬ cation of 0.1% fluorometholone sus¬ pension, most would tend to dismiss these results because of the small series.13 Another study indicated that fluorometholone causes an increase in IOP in a dose response fashion.14 The clinical impression of the Con¬ ner Glaucoma Unit was that the inci¬ dence of IOP increases with fluoro¬ metholone may be higher than re¬ ported previously. This study was undertaken to determine the inci¬ dence and degree of IOP response to 0.1% fluorometholone solution. lone is
an
matory agent with
MATERIALS AND METHODS
We frequently monitor the IOP of those patients receiving long-term topical corti¬ costeroid therapy. The participants for this study were those identified in this manner during a two-year period. Forty-three patients, 26 women and 17 men, ranging in age from 18 to 80 years were enrolled. They all demonstrated an applanation IOP rise of 5 mm Hg or more after topical treat-
ment with commercially available 0.1% dexamethasone sodium phosphate solution. The patients were treated four times daily for periods of two to seven weeks. Prior to entering the present 0.1% fluorometholone study, the IOP of each patient had returned to pretreatment values. An informed consent was obtained from each
patient
after the nature of the procedure had been fully explained. At a later time these patients received commercial 0.1% fluorometholone suspension four times a day for periods ranging between three and 11 weeks. During the study, all patients were free of any ocular disease that might interfere with the interpretation of the study data. RESULTS
The mean duration of topical thera¬ py was 5.1 weeks with dexamethasone sodium phosphate and 5.3 weeks with fluorometholone for all 43 patients. All the patients had applanation IOP elevations of 5 mm Hg or more while
using the dexamethasone sodium phosphate. Thirty of the 43 patients (69.8%) had an intraocular pressure rise of 5 to 15 mm Hg from the dexamethasone sodium phosphate and 13 patients (30.2%) experienced a pres¬ sure rise greater than 15 mm Hg Elevation of Applanation of IOP After Topical Corticosteroid Use by 43
Responders No. of Patients
Dexamethasone Fluorometholone
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15
Correlation of intraocular pressure (IOP) changes from dexamethasone and fluor¬ ometholone therapy; .433, 54, r < .001. =
c
o
The results of this study confirm that whenever long-term topical corti¬ costeroid therapy is indicated, regard¬ less of which corticosteroid is chosen, frequent monitoring of IOP should be a routine part of the patient care.
c (
O
-5
10
Change
in IOP
(Table). Twenty-six patients (60.5%)
had IOP increases of 5 mm Hg or more while receiving fluorometholone ther¬ apy. In 23 patients (53.5%) the IOP increased 5 to 15 mm Hg while they were receiving fluorometholone, and three patient (7%) demonstrated pres¬ sure rises greater than 15 mm Hg (Table). The IOP of 17 patients (39.5%) using fluorometholone remained with¬ in 4 mm Hg of baseline values
15
(mm Hg I With Fluorometholone olone the increase was 6.5 mm Hg (SD 5.2). In every case, IOP returned to baseline values following withdrawal of the steroid. COMMENT
(Table).
by though higher than other reported results, if allowed to stand alone, is not particularly alarming. However, elimination of the applanation values of those 17 pa¬
(P < .001) positive correlation re¬ sulted (Figure). The mean IOP increase with dexa¬ methasone sodium phosphate was 13.6 mm Hg (SD 3.9) and with fluorometh-
ophthalmologist.
The correlation coefficient was cal¬ culated for IOP response to dexameth¬ asone sodium phosphate vs fluoro¬ metholone. Only measurements were considered that had similar examina¬ tion times for each drug. A significant
The
mean
IOP elevation elicited
fluorometholone,
even
tients with pressure responses of less than 5 mm Hg leaves a mean IOP increase of 9.5 mm Hg (SD 4.5) for the remaining 26 patients. (Mean IOP increase after topical application of dexamethasone was 15.0 mm Hg [SD 4.0].) The fact that 26 individuals did respond to the fluorometholone treat¬ ment with such an increase in IOP should cause concern to the practicing
1. Armaly MF: Effect of corticosteroids on intraocular pressure and fluid dynamics: I. The effect of dexamethasone on the normal eye; II. Effect of dexamethasone on the glaucomatous eye. Arch Ophthalmol 70:482-499, 1963. 2. Becker B, Mills DW: Corticosteroids and intraocular pressure. Arch Ophthalmol 70:500\x=req-\ 507, 1963. 3. Podos SM, Krupin T, Asseff C, et al: Topically administered corticosteroid preparations: Comparison of intraocular pressure effects. Arch Ophthalmol 86:251-254, 1971. 4. Spaeth GL: Hydroxymethylprogesterone: An anti-inflammatory steroid without apparent effect on intraocular pressure. Arch Ophthalmol 75:783-787, 1966. 5. Knopf MM: A double-blind study of fluorometholone. Am J Ophthalmol 70:739-740, 1970. 6. Fairbairn WD, Thorson JC: Fluorometholone anti-inflammatory and intraocular pressure effects. Arch Ophthalmol 86:138-141, 1971. 7. Buch HE, Ellis RA: Clinical studies with a new steroid\p=m-\fluorometholone.Ann Ophthalmol 7:937-939, 1975. 8. Cantrill HL, Palmberg PF, Zink HA, et al: Comparison of in vitro potency of corticosteroids with ability to raise intraocular pressure. Am J Ophthalmol 79:1012-1017, 1975. 9. Bucci MG, Romani E: Effect on the ocular pressure of an anti-inflammatory drug: Fluorometholone. Boll Oculist 54:85-92, 1975. 10. Castroviejo R: Control of postoperative inflammation with fluorometholone. Klin Monatsbl Augenheilkd 166:518-520, 1975. 11. Hirata T, Choshi K: Topical application of 0.1% fluorometholone in inflammatory ocular diseases. Folia Ophthalmol Jpn 26:225-227, 1975. 12. Suzuki H, Ohaski T: Effect of topical application of fluorometholone on intraocular pressure in steroid responders. Folia Ophthalmol Jpn 25:669-675, 1974. 13. Fujita K, Takahashi T, Suzuki M: Ocular hypertensive effects of medrysone and fluorometholone by topical instillation. Jap J Clin Ophthalmol 26:1329-1335, 1972. 14. Kitazawa Y: Increased intraocular pressure induced by corticosteroids. Am J Ophthalmol 82:492-495, 1976.
Downloaded From: http://archopht.jamanetwork.com/ by a University of California - San Diego User on 01/18/2016
Response
Topically Administered Robert H.
Stewart, MD, Richard L. Kimbrough,
\s=b\Certain corticosteroids, including fluorometholone, have been reported to have a low propensity for elevating intraocular pressure. Our clinical impression that the incidence of IOP increase with fluorometholone may be higher than reported. This study was to determine the incidence and degree of IOP response to 0.1% fluorometholone suspension in 43 patients demonstrated to be responsive to 0.1% dexamethasone sodium phosphate solution. Twenty-six patients (60.5%) had IOP increases of 5 mm Hg or more while receiving fluorometholone, and three patients (7%) demonstrated pressure rises greater than 15 mm Hg. Fluorometholone can significantly raise IOP in a significant number of corticosteroid responders. was
(Arch Ophthalmol 97:2139-2140, 1979)
Tt has been documented that topical-
ly administered corticosteroids can produce a transient rise in intraocular pressure in a select population.1·2 Podos et al have reported that certain corticosteroids such as medrysone and drocinonide phosphate potassium are effective ocular anti-inflammatory agents that do
not show
a
strong
tendency to elevate the IOP.1 Spaeth has reported that medrysone is a
useful steroid that does not have a propensity for increasing IOP.4 Knopf also has reported that fluorometho-
Accepted for publication March 7, 1979. From the Department of Ophthalmology and the Hermann Eye Center, Conner Glaucoma Unit, University of Texas Medical School, Houston.
Reprint requests
to Hermann
Conner Glaucoma Unit, 1203 Ross Houston, TX 77030 (Dr Stewart).
Eye Center, Sterling Ave,
to
Fluorometholone
MD
effective ocular anti-inflam¬ a low propensity for elevating IOP.5 Several clinical studies have been fluorometholone conducted with where IOP was observed. The results of most of these studies show that fluorometholone has a substantially reduced tendency to increase IOP causing a very mild or no increase in IOP.6"" These studies tend to lull the clinical ophthalmologists into assum¬ ing that these preparations can be used with relative impunity and that significant pressure elevations are uncommon. Even though one study has shown that a rise in IOP was induced in two of three corticosteroid responders following the topical appli¬ cation of 0.1% fluorometholone sus¬ pension, most would tend to dismiss these results because of the small series.13 Another study indicated that fluorometholone causes an increase in IOP in a dose response fashion.14 The clinical impression of the Con¬ ner Glaucoma Unit was that the inci¬ dence of IOP increases with fluoro¬ metholone may be higher than re¬ ported previously. This study was undertaken to determine the inci¬ dence and degree of IOP response to 0.1% fluorometholone solution. lone is
an
matory agent with
MATERIALS AND METHODS
We frequently monitor the IOP of those patients receiving long-term topical corti¬ costeroid therapy. The participants for this study were those identified in this manner during a two-year period. Forty-three patients, 26 women and 17 men, ranging in age from 18 to 80 years were enrolled. They all demonstrated an applanation IOP rise of 5 mm Hg or more after topical treat-
ment with commercially available 0.1% dexamethasone sodium phosphate solution. The patients were treated four times daily for periods of two to seven weeks. Prior to entering the present 0.1% fluorometholone study, the IOP of each patient had returned to pretreatment values. An informed consent was obtained from each
patient
after the nature of the procedure had been fully explained. At a later time these patients received commercial 0.1% fluorometholone suspension four times a day for periods ranging between three and 11 weeks. During the study, all patients were free of any ocular disease that might interfere with the interpretation of the study data. RESULTS
The mean duration of topical thera¬ py was 5.1 weeks with dexamethasone sodium phosphate and 5.3 weeks with fluorometholone for all 43 patients. All the patients had applanation IOP elevations of 5 mm Hg or more while
using the dexamethasone sodium phosphate. Thirty of the 43 patients (69.8%) had an intraocular pressure rise of 5 to 15 mm Hg from the dexamethasone sodium phosphate and 13 patients (30.2%) experienced a pres¬ sure rise greater than 15 mm Hg Elevation of Applanation of IOP After Topical Corticosteroid Use by 43
Responders No. of Patients
Dexamethasone Fluorometholone
Downloaded From: http://archopht.jamanetwork.com/ by a University of California - San Diego User on 01/18/2016
15
Correlation of intraocular pressure (IOP) changes from dexamethasone and fluor¬ ometholone therapy; .433, 54, r < .001. =
c
o
The results of this study confirm that whenever long-term topical corti¬ costeroid therapy is indicated, regard¬ less of which corticosteroid is chosen, frequent monitoring of IOP should be a routine part of the patient care.
c (
O
-5
10
Change
in IOP
(Table). Twenty-six patients (60.5%)
had IOP increases of 5 mm Hg or more while receiving fluorometholone ther¬ apy. In 23 patients (53.5%) the IOP increased 5 to 15 mm Hg while they were receiving fluorometholone, and three patient (7%) demonstrated pres¬ sure rises greater than 15 mm Hg (Table). The IOP of 17 patients (39.5%) using fluorometholone remained with¬ in 4 mm Hg of baseline values
15
(mm Hg I With Fluorometholone olone the increase was 6.5 mm Hg (SD 5.2). In every case, IOP returned to baseline values following withdrawal of the steroid. COMMENT
(Table).
by though higher than other reported results, if allowed to stand alone, is not particularly alarming. However, elimination of the applanation values of those 17 pa¬
(P < .001) positive correlation re¬ sulted (Figure). The mean IOP increase with dexa¬ methasone sodium phosphate was 13.6 mm Hg (SD 3.9) and with fluorometh-
ophthalmologist.
The correlation coefficient was cal¬ culated for IOP response to dexameth¬ asone sodium phosphate vs fluoro¬ metholone. Only measurements were considered that had similar examina¬ tion times for each drug. A significant
The
mean
IOP elevation elicited
fluorometholone,
even
tients with pressure responses of less than 5 mm Hg leaves a mean IOP increase of 9.5 mm Hg (SD 4.5) for the remaining 26 patients. (Mean IOP increase after topical application of dexamethasone was 15.0 mm Hg [SD 4.0].) The fact that 26 individuals did respond to the fluorometholone treat¬ ment with such an increase in IOP should cause concern to the practicing
1. Armaly MF: Effect of corticosteroids on intraocular pressure and fluid dynamics: I. The effect of dexamethasone on the normal eye; II. Effect of dexamethasone on the glaucomatous eye. Arch Ophthalmol 70:482-499, 1963. 2. Becker B, Mills DW: Corticosteroids and intraocular pressure. Arch Ophthalmol 70:500\x=req-\ 507, 1963. 3. Podos SM, Krupin T, Asseff C, et al: Topically administered corticosteroid preparations: Comparison of intraocular pressure effects. Arch Ophthalmol 86:251-254, 1971. 4. Spaeth GL: Hydroxymethylprogesterone: An anti-inflammatory steroid without apparent effect on intraocular pressure. Arch Ophthalmol 75:783-787, 1966. 5. Knopf MM: A double-blind study of fluorometholone. Am J Ophthalmol 70:739-740, 1970. 6. Fairbairn WD, Thorson JC: Fluorometholone anti-inflammatory and intraocular pressure effects. Arch Ophthalmol 86:138-141, 1971. 7. Buch HE, Ellis RA: Clinical studies with a new steroid\p=m-\fluorometholone.Ann Ophthalmol 7:937-939, 1975. 8. Cantrill HL, Palmberg PF, Zink HA, et al: Comparison of in vitro potency of corticosteroids with ability to raise intraocular pressure. Am J Ophthalmol 79:1012-1017, 1975. 9. Bucci MG, Romani E: Effect on the ocular pressure of an anti-inflammatory drug: Fluorometholone. Boll Oculist 54:85-92, 1975. 10. Castroviejo R: Control of postoperative inflammation with fluorometholone. Klin Monatsbl Augenheilkd 166:518-520, 1975. 11. Hirata T, Choshi K: Topical application of 0.1% fluorometholone in inflammatory ocular diseases. Folia Ophthalmol Jpn 26:225-227, 1975. 12. Suzuki H, Ohaski T: Effect of topical application of fluorometholone on intraocular pressure in steroid responders. Folia Ophthalmol Jpn 25:669-675, 1974. 13. Fujita K, Takahashi T, Suzuki M: Ocular hypertensive effects of medrysone and fluorometholone by topical instillation. Jap J Clin Ophthalmol 26:1329-1335, 1972. 14. Kitazawa Y: Increased intraocular pressure induced by corticosteroids. Am J Ophthalmol 82:492-495, 1976.
Downloaded From: http://archopht.jamanetwork.com/ by a University of California - San Diego User on 01/18/2016
