Pharmacological management of night vision disturbances after refractive surgery: Results of a randomized clinical trial
Accepted 18 February 2005.
Purpose
To evaluate the efficacy and safety of diluted aceclidine eyedrops in reducing night vision disturbances after refractive surgery.
Setting
Department of Ophthalmology, Istituto Clinico Humanitas, Rozzano-Milano, Italy.
Methods
This double-masked randomized clinical trial included 30 patients (60 eyes) with chronic night vision disturbance after refractive surgery. Patients were randomly allocated to receive (1) placebo, (2) aceclidine 0.016%, or (3) aceclidine 0.032%. Drugs were administered once or twice daily. Anterior segment, haze, uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal maps, and scotopic pupil size were determined at baseline and at follow-up examinations (15 and 30 days after inclusion). Halos and double vision 4-step scales were built to determine subjective grading of night vision disturbance, and the root mean square (RMS) was calculated to determine objective changes in night vision disturbance.
Results
The effect of diluted aceclidine started about 15 minutes after instillation and lasted for about 5 hours. No difference between the 2 dilutions could be found. Thirty-nine of 40 treated eyes showed a reduction in night vision disturbance. The mean reduction in halos and double vision grading was 1.42 ± 0.5 (SD) and 1.14 ± 0.4, respectively. A mean decrease in pupil size of 2.5 mm was measured. Thirty minutes after the instillation of diluted aceclidine, the topography-derived wavefront error showed a statistically significant reduction in RMS values (total, spherical, astigmatic, coma, and higher order), which was maintained for 5 hours. A transitory conjunctival hyperemia was the only side effect reported.
Conclusion
Diluted aceclidine seemed to be an effective and safe treatment for night vision disturbance following refractive surgery.
From the Department of Ophthalmology (Randazzo, Vinciguerra), Istituto Clinico Humanita–Rozzano, the Oftalmologia e Futuro (Nizzola), Modena, and the University of Milan at San Paolo Hospital (Rossetti, Orzalesi), Milan, Italy
Reprint requests to Alessandro Randazzo, MD, Via Veneto 9/7, 20068 Peschiera Borromeo, Milano, Italy.
Presented at Refr@ctive On-line, Milan, Italy, September 2002, and at the 8th Annual Nidek International Excimer Laser Symposium, Shanghai, China, December 2002.
No author has a financial or proprietary interest in any material or method mentioned. Patent pending.
ABSTRACT