Five years follow-up of CO2 laser assisted sclerectomy surgery (CLASS) in open angle glaucoma patients: a multi-center study report
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Session Details
Session Title: Glaucoma I
Session Date/Time: Monday 07/09/2015 | 08:00-10:30
Paper Time: 10:16
Venue: Room 10
First Author: : N.Geffen ISRAEL
Co Author(s): : M. Mimouni E. Assia
Abstract Details
Purpose:
To evaluate the long term efficacy and safety of CO2 Laser Assisted Sclerectomy Surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma.
Setting:
A prospective, single-arm, non-randomized clinical trial at 9 centers worldwide.
Methods:
Candidates for primary filtration surgery with POAG or PEXG, with baseline IOP higher than18 mmHg on maximal treatment were included. The CLASS procedure (“IOPtiMate”; IOPtima Ltd, Israel) was performed. A half- thickness scleral flap was created and the CO2 laser was used to achieve deep scleral ablation and un-roofing of Schlemm's Canal.
Intraocular pressure (IOP) and use of medications were collected at baseline and up to 5 years follow up. Complete success was defined as 5≤ IOP≤ 18 mmHg and 20% IOP reduction with no medications, and qualified success with or without medications. All adverse events were recorded
Results:
111 consecutive eyes were enrolled, 11 excluded. Mean age was 69.3 ± 12.8 years, 73.9% were Caucasians. IOP was reduced from 25.8±5.4mmHg to 13.5±4.0mmHg, 14.2±2.9mmHg and 14.1±3.1mmHg at 1, 3 and 5 years follow up, respectively. The qualified success rates after 1, 3 and 5 years were 79.6%, 86.7% and 80.0%, respectively. The average number of medications dropped from 2.41±1.25 to 0.5±0.8, 0.7±0.9 and 0.9±0.8 at 1, 3 and 5 years follow up respectively (P < 0.001). No technical device malfunctions occurred. Complications were mostly mild and transitory with no significant sequela.
Conclusions:
Long term results suggest that CLASS procedure is a safe, effective, and simple technique for treating patients with open-angle glaucoma.
Financial Interest:
One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented