Abstract
PURPOSE: To assess the safety and efficacy of adjuvant combination therapy using 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) for prevention of proliferative vitreoretinopathy (PVR) after vitrectomy and retinal reattachment surgery.
DESIGN: Prospective randomized, double-masked, placebo controlled trial.
PARTICIPANTS: One hundred seventy-four high-risk patients were randomized to receive either 5-FU and LMWH therapy or placebo. Patients were selected from all patients undergoing primary vitrectomy for rhegmatogenous retinal detachment.
METHOD: Results of standard surgery with 5-FU and LMWH therapy or placebo were compared at the 6-month follow-up.
MAIN OUTCOME MEASURES: Development of postoperative PVR, retinal reattachment at 6 months after surgery, single operation reattachment rate, number of reoperations, and best-corrected visual acuity.
RESULTS: There were 87 patients in the 5-FU and LMWH therapy group and 87 in the placebo group. The incidence of postoperative PVR was significantly lower (P = 0.02) in the 5-FU and LMWH therapy compared with the placebo group. In 26.4% (23/87) of the placebo group and in 12.6% (11/87) of the 5-FU and LMWH group, postoperative PVR developed. In the 5-FU and LMWH group, the number of patients undergoing more than one operation was 19.5% (17/87) and the number of reoperations resulting from PVR was 52.9% (9/17). In the placebo group, the number of patients undergoing more than one operation was 25.3% (22/87) and the number of reoperations resulting from PVR was 72.7% (16/22). The difference in visual acuity was not statistically different in the two treatment groups, although those patients in whom postoperative PVR developed tended to have poorer vision (P < 0.0001). There were no differences in complication rates between the two groups.
CONCLUSIONS: There is a significant reduction in the incidence of postoperative PVR in patients receiving the 5-FU and LMWH therapy and in the reoperation rate resulting from PVR. This trial shows that incidence of PVR can be reduced with inexpensive and simple pharmacologic treatment with 5-FU and LMWH and should be used routinely in the treatment of patients at risk of developing PVR.
Original language | English |
---|---|
Pages (from-to) | 1179-83 |
Number of pages | 5 |
Journal | Ophthalmology |
Volume | 108 |
Issue number | 7 |
Publication status | Published - Jul 2001 |
Keywords
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Fluorouracil
- Follow-Up Studies
- Heparin, Low-Molecular-Weight
- Humans
- Male
- Middle Aged
- Prospective Studies
- Retinal Detachment
- Risk Factors
- Safety
- Visual Acuity
- Vitrectomy
- Vitreoretinopathy, Proliferative
- Clinical Trial
- Comparative Study
- Journal Article
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't