Original ArticleRandomized Controlled Trial of Combined 5-Fluorouracil and Low-Molecular-Weight Heparin in the Management of Unselected Rhegmatogenous Retinal Detachments Undergoing Primary Vitrectomy
Section snippets
Materials and Methods
Patients were recruited who had a rhegmatogenous retinal detachment to be managed by primary vitrectomy with intraocular gas tamponade, to include males over 16 years of age and postmenopausal women. The leading indications for primary vitrectomy surgery included retinal detachment with a posterior vitreous detachment owing to superior posterior, multiple, or tractional retinal breaks, pseudophakia, and/or an inadequate view of the fundus, for example, secondary to vitreous hemorrhage. Eyes
Results
Six hundred forty-one patients were recruited from 2 specialized vitreoretinal units—Moorfields Eye Hospital, London (n = 553) and St. Pauls Eye Unit, Liverpool (n = 88) between February 2001 and January 2005. Of the 641 patients who were recruited, 342 were randomly assigned to the treatment group and 299 to the placebo group. Figure 1 documents the progress of patients through the trial.
The baseline characteristics of the 2 groups were similar and are presented in Table 1. The mean age of
Discussion
The overall primary anatomic success rate of retinal detachment surgery in this study was 84.4%. At 6 months, the complete reattachment rate was 97.9% and the macular attachment rate was 99.7%. These results compare favorably with current published data1, 2, 5, 7, 21 and are consistent with that seen in specialist units.21 Recruitment of patients for this trial reflects the current management of retinal detachment in the 2 units involved: 70% to 80% of primary rhegmatogenous retinal detachments
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Manuscript no. 2006-163.
Financial support: Royal Blind Asylum/Royal College of Surgeons, Edinburgh, United Kingdom, and Special Trustees of Moorfields Eye Hospital.