Randomized, Controlled Trial of a Sustained Delivery Formulation of 5-Fluorouracil for the Treatment of Failing Blebs
To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling. Prospective, randomized, controlled trial. Fifty patients with previous trabeculectomy and scheduled by the managing physician f...
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Published in | Ophthalmology (Rochester, Minn.) Vol. 119; no. 2; pp. 314 - 320 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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New York, NY
Elsevier Inc
01.02.2012
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ISSN | 0161-6420 1549-4713 1549-4713 |
DOI | 10.1016/j.ophtha.2011.07.053 |
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Abstract | To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling.
Prospective, randomized, controlled trial.
Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention.
One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone.
The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology.
Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6,
P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (
P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4–8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2–8.2];
P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (
P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%;
P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups.
Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings.
The author(s) have no proprietary or commercial interest in any materials discussed in this article. |
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AbstractList | To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling.
Prospective, randomized, controlled trial.
Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention.
One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone.
The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology.
Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6,
P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (
P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4–8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2–8.2];
P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (
P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%;
P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups.
Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings.
The author(s) have no proprietary or commercial interest in any materials discussed in this article. To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling.PURPOSETo determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling.Prospective, randomized, controlled trial.DESIGNProspective, randomized, controlled trial.Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention.PARTICIPANTSFifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention.One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone.METHODSOne eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone.The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology.MAIN OUTCOME MEASURESThe primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology.Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4-8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2-8.2]; P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups.RESULTSForty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4-8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2-8.2]; P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups.Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings.CONCLUSIONSSubconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings. To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling. Prospective, randomized, controlled trial. Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention. One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone. The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology. Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group (P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4-8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2-8.2]; P<0.001 for both). Intergroup comparisons for IOP change from baseline was not significant (P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups. Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings. Purpose To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function by needling. Design Prospective, randomized, controlled trial. Participants Fifty patients with previous trabeculectomy and scheduled by the managing physician for a needling intervention. Methods One eye of each patient was randomized to receive needling with HA-5FU mixture or needling with subconjunctival injection of 5FU solution alone. Main Outcome Measures The primary outcome was the percentage of subjects with an intraocular pressure (IOP) <15 mmHg without any medications at 3 months. Secondary outcomes included the need for additional needling procedures and changes in bleb morphology. Results Forty-nine subjects (25 in the HA-5FU group and 24 in the 5FU group) completed 3 months of follow-up. At baseline, there was no significant difference between the groups in terms of demographic features, subtype of glaucoma, vertical cup-to-disc ratio, or visual field indices. The mean number of glaucoma medications at baseline was higher in the 5FU group (0.8±1.1 [mean ± standard deviation] vs. 0.2±0.6, P = 0.04). An IOP <15 mmHg without medications was reached in 48.0% of subjects in the HA-5FU group and in 33.3% of subjects in the 5FU group ( P = 0.2). At 3 months, both groups demonstrated a significant decrease in IOP from baseline (HA-5FU: decrease of 5.9 mmHg [95% confidence interval, 3.4–8.4]; 5FU: decrease of 6.0 mmHg [95% confidence interval, 3.2–8.2]; P <0.001 for both). Intergroup comparisons for IOP change from baseline was not significant ( P = 0.9). However, repeat needling was required more frequently in the 5FU group compared with the HA-5FU group (50.0% vs. 12.0%; P = 0.004). There were no significant differences in the number of reported adverse events, bleb vascularity, or morphology between the 2 groups. Conclusions Subconjunctival injection of HA-5FU to revive bleb function after bleb needling is as effective as 5FU solution. Fewer repeat needlings were required after treatment with HA-5FU, suggesting that the use of a combined formulation of HA-5FU may improve the overall outcomes of bleb needlings. Financial Disclosure(s) The author(s) have no proprietary or commercial interest in any materials discussed in this article. |
Author | Zhen, Ma Wong, Tina Tzee Ling Chua, Jocelyn Zheng, Ce Boey, Pui Yi Venkatraman, Subramanian Narayanaswamy, Arun Kumar Lee, Kelvin Chai, Shu Ming Aung, Tin |
Author_xml | – sequence: 1 givenname: Arun Kumar surname: Narayanaswamy fullname: Narayanaswamy, Arun Kumar organization: Singapore Eye Research Institute, Singapore – sequence: 2 givenname: Kelvin surname: Lee fullname: Lee, Kelvin organization: Singapore Eye Research Institute, Singapore – sequence: 3 givenname: Ma surname: Zhen fullname: Zhen, Ma organization: School of Materials Science and Engineering, Nanyang Technological University, Singapore – sequence: 4 givenname: Jocelyn surname: Chua fullname: Chua, Jocelyn organization: Glaucoma Service, Singapore National Eye Centre, Singapore – sequence: 5 givenname: Shu Ming surname: Chai fullname: Chai, Shu Ming organization: Glaucoma Service, Singapore National Eye Centre, Singapore – sequence: 6 givenname: Pui Yi surname: Boey fullname: Boey, Pui Yi organization: Glaucoma Service, Singapore National Eye Centre, Singapore – sequence: 7 givenname: Ce surname: Zheng fullname: Zheng, Ce organization: Singapore Eye Research Institute, Singapore – sequence: 8 givenname: Tin surname: Aung fullname: Aung, Tin organization: Singapore Eye Research Institute, Singapore – sequence: 9 givenname: Subramanian surname: Venkatraman fullname: Venkatraman, Subramanian organization: School of Materials Science and Engineering, Nanyang Technological University, Singapore – sequence: 10 givenname: Tina Tzee Ling surname: Wong fullname: Wong, Tina Tzee Ling email: tina.wong.t.l@snec.com.sg organization: Singapore Eye Research Institute, Singapore |
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Keywords | Antineoplastic agent Enzyme Controlled release form Fluoropyrimidine derivatives Transferases Enzyme inhibitor Thymidylate synthase Controlled delivery Treatment Antimetabolic Methyltransferases Pyrimidine derivatives Clinical trial Ophthalmology Fluorouracil |
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Snippet | To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb function... Purpose To determine the efficacy of a subconjunctival injection of hyaluronic acid (HA) with 5-fluorouracil (5FU) formulation as an adjunct in reviving bleb... |
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SubjectTerms | Aged Aqueous Humor - secretion Biological and medical sciences Conjunctiva - drug effects Delayed-Action Preparations Female Fluorouracil - administration & dosage Glaucoma - physiopathology Glaucoma - surgery Humans Hyaluronic Acid - administration & dosage Intraocular Pressure - physiology Male Medical sciences Miscellaneous Needles Ophthalmology Ostomy - methods Prospective Studies Tomography, Optical Coherence Tonometry, Ocular Trabeculectomy Treatment Failure |
Title | Randomized, Controlled Trial of a Sustained Delivery Formulation of 5-Fluorouracil for the Treatment of Failing Blebs |
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