A Prospective Clinical Trial on the Use of AlphaganTM as a Neuro-protective Agent in Retinal Detachment Visual Recovery

Abstract

Abstract: : Purpose: To prospectively compare the effects of Alphagan^TM on the rate and degree of visual recovery after surgical repair of a primary macula-off retinal detachment, compared to recovery without the use of Alphagan^TM. Methods: This prospective, randomized, study examined the effectiveness of Alphagan^TM as a neural-protective agent in the prevention of cellular apoptosis occurring with retinal detachment. All patients were treated for their detachment, and prior to surgery or pneumatic repair were randomly assigned to one of two treatment arms (Alphagan or placebo) for a treatment period of 6 weeks. The primary outcome examined in this protocol is that of post-operative visual acuity recovery in the presence of anatomic reattachment. Secondary outcomes include electro-retinogram results, and duration of macular detachment. Results: A total of 50 patients were prospectively enrolled during the study period from the clinical practice of 5 University based retinal specialists. Enrolled patients were randomly assigned to either Alphagan^TM or Placebo (Tear Formula), three times a day for 6 weeks following repair. All patients were treated with either Vitrectomy, Scleral Buckle or Pneumatic Retinopexy based on the clinical judgement of the investigator. Anatomic reattachment was acheived in all cases. Average logMAR visual acuity at the time of enrollment was 1.90 (1.00-3.00 logMAR equivalent). Visual improvement was calculated in logMAR equivalents. Average visual improvement in the treatment arm was 1.34 logMAR equivalents, and 1.08 LogMar equivalents for the placebo groups. A 2 tailed t-test calculated between the treatment and control groups did not indicate any statistical significance (t-test value 0.35) for best recorded visual outcome. Conclusions: The sample size did not indicate any statistical significance in post-op visual acuity recovery between patients treated with Alphagan^TM and placebo.

Keywords: retina • neuroprotection • clinical (human) or epidemiologic studies: out