Long-term results of CO2 laser-assisted sclerectomy surgery (CLASS) for open-angle glaucoma treatment

Session Details

Session Title: Glaucoma II

Session Date/Time: Monday 15/09/2014 | 08:00-10:30

Paper Time: 08:19

Venue: Boulevard F (Level 1)

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 cumulative data from prospective, single-arm, multi-national clinical trials. The clinical trials were carried out in 9 medical centers located in 7 countries: Mexico, India, Russia, Italy, Spain, Swiss and Israel.

Methods:

Candidates for primary filtration surgery underwent CLASS procedure ('IOPtiMate™', IOPtima Ltd, Israel). The system gradually ablates and removes scleral layers until percolating fluid absorbs the energy, attenuating further tissue ablation. Intraocular pressure (IOP) was measured at baseline, 1, 2, 4 and 6 weeks, and 3, 6, 12, 24 and 36 months. Complete success was defined as 5≤ IOP≤ 18 mmHg and 20% IOP reduction with no medications, and qualified success as the same IOP range with or without medications. All adverse events were recorded and analyzed. Statistical analyses were performed using statistical program SAS ® version 9.1. The change in IOP from baseline at each follow up evaluation was analyzed using paired Student t tests with the conservative Bonferroni correction for multiple comparisons. Kaplan Meier life table curves for efficacy were built to demonstrate the duration of success.

Results:

111 consecutive eyes were enrolled in the study. 14 were excluded from the study. The mean age was 69.3 ± 12.8. 73.9% were Caucasians. 82, 53 and 29 completed 12, 24 and 36 months of follow-up by the time of writing this abstract. Mitomycin C was used in 88.8% of CLASS procedures. The percent change in IOP at 1, 2 and 3 years was respectively 45.1%, 46.8% and 41.8% (P < 0.01).The complete success rates after 12, 24 and 36 months were 60.2% (95% CI, 0.50-0.70), 57.9% (95% CI, 0.44-0.71) and 61.3% (95% CI, 0.42-0.78) respectively. The qualified success rates after 12, 24 and 36 months were 79.6% (95% CI, 0.70-0.87), 91.2% (95% CI, 0.81-0.97) and 90.3% (95% CI, 0.74-0.98) respectively. The average number of medications dropped from 2.41 ± 1.25 to 0.46 ± 0.83, 0.53 ± 0.75 and 0.55 ± 0.83 at 12, 24 and 36 months respectively (P < 0.001). No technical device malfunctions occurred and complications were mostly mild and transitory with no significant sequela.

Conclusions:

Long term results suggest that CLASS may become simple, safe and effective means of choice for OAG treatment.

Financial Interest:

One or more of the authors... gains financially from product or procedure presented, One or more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented