Document Detail

5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial.
MedLine Citation:
PMID:  9052620     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To test the effect of postoperative subconjunctival 5-fluorouracil (5-FU) on the pressure outcome in combined procedure (limbus-based trabeculectomy + clear-cornea phacoemulsification). METHODS: Prospective randomized, controlled clinical trial; n = 24 eyes (24 patients) with concurrent open-angle glaucoma and cataract; 12 eyes per treatment group; sample size adjusted for a minimal expected difference in the event rate between the 2 treatment groups = 50%, control rate = 20%; type I error = 0.05; power = 95%. Uncomplicated limbus-based trabeculectomy + uncomplicated clear-cornea phacoemulsification + posterior chamber intraocular lens. The 5-FU group = five subconjunctival injections of 5 mg 5-FU, starting from day 8 after surgery, one injection per week. Control group = no injections. The groups were matched for age, preoperative intraocular pressure (IOP), duration of preoperative antiglaucoma treatment, preoperative pilocarpine and adrenergics, preoperative laser trabeculoplasty, and beta-blockers in the fellow eye. The IOP less than or equal to 15 mmHg without treatment 1 year after surgery (IOP = average of the two highest values measured in the diurnal curve, 8 AM to 6 PM, one reading every 2 hours). RESULTS: Each patient completed a 1-year follow-up. Ten of 12 eyes of the 5-FU group showed an IOP less than or equal to 15 mmHg at the end of follow-up versus 1 of 12 eyes in the control group (Fisher's exact test, P = 0.00064). The IOP range was 10 to 17 mmHg in the 5-FU group and 14 to 22 mmHg in the control group. CONCLUSION: Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification.
S A Gandolfi; M Vecchi
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Ophthalmology     Volume:  104     ISSN:  0161-6420     ISO Abbreviation:  Ophthalmology     Publication Date:  1997 Feb 
Date Detail:
Created Date:  1997-03-18     Completed Date:  1997-03-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  181-6     Citation Subset:  IM    
Glaucoma Service, University of Parma, Italy.
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MeSH Terms
Antimetabolites / administration & dosage*
Cataract / complications
Cornea / surgery*
Fluorouracil / administration & dosage*
Follow-Up Studies
Glaucoma, Open-Angle / complications,  physiopathology,  surgery*
Intraocular Pressure / drug effects,  physiology
Lenses, Intraocular*
Middle Aged
Postoperative Care
Prospective Studies
Visual Acuity
Reg. No./Substance:
0/Antimetabolites; 51-21-8/Fluorouracil
Comment In:
Ophthalmology. 1997 Oct;104(10):1527-8   [PMID:  9331183 ]

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