Purpose:
To compare the safety and efficacy of the Ahmed Glaucoma Valve (model FP7) to the Baerveldt Glaucoma Implant (model 101-350) in patients with refractory glaucoma after three years of follow-up.
Methods:
Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an Ahmed or a Baerveldt implant. The main outcome measures were IOP, visual acuity, use of supplemental medical therapy, complications, and failure (IOP > 21 mm Hg or not reduced by 20%, IOP ≤ 5 mm Hg, reoperation for glaucoma or removal of implant, or loss of light perception vision).
Results:
Retention rates at 18, 24, and 36 months respectively were 92%, 87%, and 75%. The risk of failure by any criterion was similar for the Ahmed and Baerveldt implants (risk ratio = 1.0, p=0.88, 95% CI=0.7, 1.6); however, the risk of reoperation for glaucoma was 2.0 times higher with the Ahmed implant than the Baerveldt implant (p=0.074, 95% CI=0.9, 4.4). At 36 months, mean (SD) IOP was 14.3 mmHg (4.9) in the Ahmed group and 12.9 mmHg (4.4) in the Baerveldt group (p=0.049). The mean (SD) number of IOP lowering medicines was 1.9 (1.4) in the Ahmed group and 1.5 (1.4) in the Baerveldt group (p=0.048).
Conclusions:
There was no difference in failure rates, but the modestly better intraocular pressure control with the Baerveldt implant compared to the Ahmed implant seen at one year follow-up persisted through 3 years.
Clinical Trial:
http://www.clinicaltrials.gov NCT00376363
Keywords: clinical (human) or epidemiologic studies: outcomes/complications