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BACKGROUND: This is the first randomized controlled trial of trabeculectomy with Ex-Press Shunt versus Ologen implant in primary open-angle glaucoma (POAG) in Indian eyes. METHODS: A prospective randomized controlled trial of patients of POAG treated with two different methods of augmented trabeculectomy. Group A with Ex-PRESS shunt (P50 model) and Group B with Ologen implant. Surgical success was defined as intraocular pressure of 21 mm Hg or lower at 6 months postoperative. RESULTS: N = 40 eyes of 33 patients. Baseline IOP in Group A was 23.70 ± 4.6 mm Hg (Range 22-36 mm Hg), and Group B was 26.00 ± 4.0 mm Hg (Range 23-36 mm Hg). Surgical success was achieved in 85% of patients in both Groups. Change in IOP from baseline was statistically significant in both groups at 1, 4, 8, 12 weeks, and 6 months postoperative. No statistically significant difference in the change in IOP between the two groups. Postoperative complications were lesser in Group A compared to Group B, in both early (35% vs 50%) and late stage (20% vs 30%). The drop in visual acuity became statistically insignificant at 4 weeks in Group A and 8 weeks in Group B. CONCLUSIONS: There is no difference between the surgical success rates of trabeculectomy with Ex-PRESS Shunt versus Ologen. However, the Ex-PRESS shunt fares better with lower complication rates and faster visual recovery than the Ologen group.
Classified Specialist (Ophthalmology), Command Hospital (CC), Lucknow, India.
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