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Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year
Author(s) -
Narayanaswamy Arun,
Perera Shamira A,
Htoon Hla M,
Hoh SekTien,
Seah Steve K,
Wong Tina T,
Aung Tin
Publication year - 2013
Publication title -
clinical and experimental ophthalmology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.3
H-Index - 74
eISSN - 1442-9071
pISSN - 1442-6404
DOI - 10.1111/ceo.12058
Subject(s) - medicine , intraocular pressure , mitomycin c , confidence interval , dry needling , glaucoma , phacoemulsification , trabeculectomy , surgery , glaucoma surgery , ophthalmology , implant , adverse effect , gonioscopy , randomized controlled trial , visual acuity , alternative medicine , pathology , acupuncture
Background To assess the efficacy and safety of collagen matrix implant ( O logen) in phacotrabeculectomy.Design Prospective, non‐randomized, comparative study. Participants Sixty‐six A sian patients.Methods Thirty three consecutive patients underwent phacotrabeculectomy with O logen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7–19.2) in the O logen group and 26% (95% confidence interval 14.8–37.9) in the mitomycin C group ( P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8–5.6 mmHg ) and 5.6 mmHg (95% confidence interval 4.2–7.0 mmHg ), respectively ( P = 0.16). Needling with 5‐fluorouracil was required more often in the O logen group (39% vs. 6%; P = 0.003). There was similar frequency (<10%) of adverse events in both groups, and there were no complications directly related to the O logen implant. The blebs in the mitomycin C group had greater central area ( P = 0.005), maximal area ( P = 0.01) and height ( P = 0.005), and were less vascular ( P = 0.023) than the O logen blebs. Conclusions A t 1 year, the overall performance of O logen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C . Eyes in the O logen group required more frequent bleb needling procedures.