الفهرس 
Introduction
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Abstract
The purpose of our study was to compare the efficacy and safety of Trabeculectomy augmented by Ologen collagen implant with Trabeculectomy augmented by different concentrations of Mitomycin C. We conducted a prospective interventional open-label, non-randomized clinical study in the Department of Ophthalmology, Assiut University Hospital, Egypt from August 2014 till May 2016. Thirty patients suffering from POAG, CACG and secondary OAG (PXG and PDG) were included. Patients with CACG or OAG with previous ocular surgery (including glaucoma surgery) or previous ocular trauma were excluded. All participants underwent pre-operative complete ophthalmic examination, fundus examination and IOP measurement by Goldmann Applanation Tonometer. Patients were assigned to 3 groups; Trabeculectomy augmented by Ologen collagen implant or MMC 0.4 mg/mL and MMC 0.2 mg/mL. Patients were followed for 6 months. Primary outcome measure was final IOP measurements at 6-months follow up. Secondary outcome measures were success rate proportions, correlation between preoperative parameters and success rate and final IOP at 6 months, survival analysis and rate of complications among treatment groups.
The study included 17 male and 13 female. Mean age of patients assigned to Ologen (OLO), MMC 0.4 and MMC 0.2 were 54.7 ± 6.36, 51.9 ± 10.04 and 53.3 ± 11.92 years respectively. About 85 % of scheduled follow-up visits were achieved. CACG was diagnosed in 15 cases, POAG in 12 cases, PXG in 2 cases and a single case of PDG. Mean preoperative IOP in Ologen, MMC 0.4 and MMC 0.2 groups were 27.43 ± 2.97, 28.4 ± 3.24 and 27.56 ± 2.69 mmHg respectively with no significant difference among treatment groups. At 6-months follow up, mean IOP in Ologen, MMC 0.4 and MMC 0.2 groups were 18.55 ± 3.18, 16.2 ± 3.22, 16.93 ± 3.04 mmHg respectively. No inter-group significant difference was noticed at any scheduled postoperative follow up visit.
Preoperative IOP measurements were significantly, strongly and positively correlating with final IOP at 6 months (Pearson Correlation Coefficient; r = 0.725, p value = 0.018 in Ologen group, r = 0.844, p value = 0.002 in MMC 0.4 group, r = 0.792, p value = 0.006 in MMC 0.2 group). There were insignificant variable correlation between IOP measurements at 6 months and anti-glaucoma medications, angle grading by gonioscopy and CDR by at Preoperative evaluation. A complete success was achieved in 1 eye (10%), 4 eyes (40%) and 3 eyes (30%) in Ologen, MMC 0.4 mg/ml and MMC 0.2 mg/ml groups respectively, while incomplete success in 7 eyes (70%), 5 eyes (50%) and 6 eyes (60%) in Ologen, MMC 0.4 and MMC 0.2 groups respectively. Surgical failure was reported in four cases (2 in OLO group, and 1 in each MMC group). Noteworthy that 3 cases of surgical failure occurred in patients suffering from CACG. Such finding should point our attention towards the role of cataract extraction in the management of CACG. Shallow AC was reported in Ologen (4 eyes) and MMC 0.4 (4 eyes) groups than MMC 0.2 (3 eyes). Hypotony also was reported in a higher rate in MMC 0.4 mg/ml and 0.2 mg/ml groups (3 and 2 eyes respectively) than in Ologen group (1 eye). One case of serous choroidal effusion occurred in MMC 0.4 mg/ml group. Bleb-related infection did not occur in any of treatment groups.
On the light of the present data, we can conclude that Ologen implant may be a safe and effective alternative to MMC for improving the success rate of trabeculectomy surgery and may avoid the side effects associated with the use of MMC.