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B. Zack, M. Chipman, G. Trope, D. Rootman, A. Slomovic, Y. Buys; A Prospective Randomized Comparison of One– versus Two–Site Phacotrabeculectomy . Invest. Ophthalmol. Vis. Sci. 2005;46(13):105.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate intraocular pressure lowering following one– versus two–site phacotrabeculectomy. Methods: Eligible patients scheduled for phacotrabeculectomy were randomized to either one–site or two–site surgery. Data recorded included patient demographics, best–corrected visual acuity, IOP, endothelial cell counts and number of glaucoma medications. Also, phacoemulsification settings (including power, ultrasound time and fluid volume), iris manipulation, post–operative suture lysis, 5FU or needling were recorded along with any complications. Follow–up data were obtained for 3 months, 6 months, 1 year and 2 years. Results: Of 80 patients enrolled, 73 patients have completed 3 months post–operative follow–up (37 one–site; 36 two–site). 64 patients have completed 6 months post–operative follow–up. 47 patients have completed 12 months post–operative follow–up. Pre–operative mean IOP was 17.6+/–4.7 mmHg (range 12–36) (one–site) and 17.6+/–5.5 mmHg (range 10–34) (two–site), p=0.49. There were no significant differences in the demographics of each group. Intraoperative complications occurred in 3 patients (one–site) (partial flap dehiscence, zonular dehiscence, posterior capsular rupture), and 3 patients (two–site) (incision tore to limbus, conjunctival button hole, posterior capsular rupture). Post–operative complications occurred in 5 patients (one–site) (diabetic macular edema, diabetic vitreous hemorrhage, suture infection, traumatic globe rupture, wound dehiscence), and 0 patients (two–site) p=0.055. The mean IOP at 3 months post–operative was 12.7+/–6.2 mmHg (one–site), and 11.8+/–3.5 mmHg (two–site), p=0.39. Mean decrease in IOP was 4.9 +/– 7.3 mmHg (28%) versus 5.6 +/– 6.6 mmHg (32%, p=0.67), 4.9+/–6.1 mmHg (28%) versus 5.7+/–5.7 mmHg (32%, p=0.59), and 4.7+/–5.0 mmHg (27%) versus 6.8+/–5.8 mmHg (39%, p=0.20), for one– versus two–site at 3, 6 and 12 months respectively. There was a significant lowering of IOP compared to pre–operative baseline IOP for both groups at all time points (p< 0.05). The mean number of glaucoma medications at 3,6 and 12 months decreased from a mean of 2.9 and 2.9 to 0.0 and 0.1 for one– and two–site respectively, p=0.99. Conclusions: Interim data at 3, 6 and 12 months follow–up show no statistical difference in IOP between the groups although there appears to be a trend to lower IOP in the two–site group. Both groups also had similar, significant reductions in their medications and improvements in their visual acuity.
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