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S.A. Gandolfi, L. Quaranta, N. Ungaro, L. Cimino, C. Sangermani, M. Tardini, S. Bettelli; Deep Sclerectomy vs Trabeculectomy in Open Angle Glaucoma. 7–Year Prospective Randomised Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1217.
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Purpose: to compare the longterm outcomes of penetrating vs non penetrating surgeries Methods: prospective, two–center randomized investigator–masked clinical trial, Eligibility: age > 65 yrs, open angle, IOP > 23 and < 30 mmHg, at least two medications in use, previous laser trabeculoplasty, topical beta blocker in fellow eye, Mean Defect < 20 dB (24/2 Humphrey full threshold). 79 eyes (79 patients) enrolled and randomised by pseudoexfoliation and use of pilocarpine to deep sclerectomy (Group A, n = 41) or trabeculectomy (Group B, n = 38). Main efficacy outcome: % of eyes showing a IOP < 16, 18 or 21 mmHg without medications at the end of follow up. Secondary outcomes (a) changes in visual acuity (LogMAR). (b) % of enrolled eyes undergoing cataract surgery (b) changes in visual field. Length of follow up: 7 years. Statistical analysis was performed on an "intent–to–treat" basis. Power = 90%, alpha probability < 5%. Results: 2 eyes in Group A and 1 eye in Group B showed a complete failure (i.e. IOP > 20 mmHg unresponsive to needling + supplementation with subconjunctival 5–fluorouracil) within 4 months from surgery. Main efficacy outcome: (a) 21 mmHg cut–off, 43% Group A, 68% Group B, p < 0.05; (b) 18 mmHg cut–off, 18% Group A, 51% Group B, p < 0.001; (c) 16 mmHg cut–off, 3% Group A, 45% Group B, p < 0.0001. Yag–laser goniopuncture was performed during follow up in 62% of the patients randomised to DS. If goniopuncture were considered as a regular post–operative step, the 7–year success rate(s) of DS would increase as follows: 61% (21 mmHg), 40% (18 mmHg), 23% (16 mmHg). Cataract surgery was performed in 5/41 DS vs 19/38 TE. Further glaucoma surgery was performed in 8 DS vs 2 TE Conclusions: (a) trabeculectomy offered a better IOP control than deep sclerectomy 7 years after surgery; (b) when deep sclerectomy was converted to a penetrating procedure by means of post–operative Yag–laser goniopuncture, the success rate increased significantly (c).deep sclerectomy was associated with with a lower incidence of cataract extraction.
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