Rany Mitwally1, Amr Aref2, Tarek Shaarawy3. 1. Hadi Clinic, Hawalli, State of Kuwait. 2. Research Institute of Ophthalmology (RIO), Giza, Arab Republic of Egypt. 3. Geneva University Hospitals (HUG), University of Geneva, Geneva, Switzerland.
Abstract
PRCIS: Deep sclerectomy with intrascleral collagen implant (DSCI) was less effective in lowering intraocular pressure (IOP) than with suprachoroidal implantation. Further studies are needed to establish the potency and safety of deep sclerectomy with suprachoroidal collagen implant (DSSCI). PURPOSE: The purpose of this study was to analyze the safety and IOP-lowering effect of DSSCI in comparison with DSCI. SETTING: Geneva University Hospitals, Geneva, Switzerland. METHODS: This is a prospective, randomized, controlled study involving 13 patients (26 phakic eyes) with bilateral medically uncontrolled primary or secondary open-angle glaucoma. Bilateral deep sclerectomy was performed with each patient being randomly assigned to receive a collagen implant in the intrascleral space in one eye, and a suprachoroidal collagen implant in the other. Follow-up visits were performed at day 1; at week 1; and at months 6, 9, 12, 18, 30, 48, 54, and 60. RESULTS:Mean preoperative IOP was 24.1±4.2 mm Hg for DSCI group and 25.3±5.3 mm Hg for DSSCI group (P=0.1). The mean postoperative IOP was 14.8±4.0 mm Hg (DSCI) versus 9.8±3.7 mm Hg (DSSCI) at month 60 (P=0.01). Mean preoperative best-corrected visual acuity for the DSCI group was 0.76±0.22 and 0.74±0.23 for the DSSCI group (P=0.001), while the mean postoperative best-corrected visual acuity was 0.82±0.17 (DSCI) and 0.80±0.17 (DSSCI) at month 60 (P=0.004). CONCLUSIONS:DSSCI demonstrated a greater IOP-lowering effect than deep sclerectomy with intrascleral implantation. The safety profile of both methods was similar. More patients with a longer follow-up are required to comprehensively assess the safety and efficacy of this new approach.
RCT Entities:
PRCIS: Deep sclerectomy with intrascleral collagen implant (DSCI) was less effective in lowering intraocular pressure (IOP) than with suprachoroidal implantation. Further studies are needed to establish the potency and safety of deep sclerectomy with suprachoroidal collagen implant (DSSCI). PURPOSE: The purpose of this study was to analyze the safety and IOP-lowering effect of DSSCI in comparison with DSCI. SETTING: Geneva University Hospitals, Geneva, Switzerland. METHODS: This is a prospective, randomized, controlled study involving 13 patients (26 phakic eyes) with bilateral medically uncontrolled primary or secondary open-angle glaucoma. Bilateral deep sclerectomy was performed with each patient being randomly assigned to receive a collagen implant in the intrascleral space in one eye, and a suprachoroidal collagen implant in the other. Follow-up visits were performed at day 1; at week 1; and at months 6, 9, 12, 18, 30, 48, 54, and 60. RESULTS: Mean preoperative IOP was 24.1±4.2 mm Hg for DSCI group and 25.3±5.3 mm Hg for DSSCI group (P=0.1). The mean postoperative IOP was 14.8±4.0 mm Hg (DSCI) versus 9.8±3.7 mm Hg (DSSCI) at month 60 (P=0.01). Mean preoperative best-corrected visual acuity for the DSCI group was 0.76±0.22 and 0.74±0.23 for the DSSCI group (P=0.001), while the mean postoperative best-corrected visual acuity was 0.82±0.17 (DSCI) and 0.80±0.17 (DSSCI) at month 60 (P=0.004). CONCLUSIONS: DSSCI demonstrated a greater IOP-lowering effect than deep sclerectomy with intrascleral implantation. The safety profile of both methods was similar. More patients with a longer follow-up are required to comprehensively assess the safety and efficacy of this new approach.