R Lim-Bon-Siong1, S Valluri, M E Gordon, J S Pepose. 1. Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, Missouri 63110, USA.
Abstract
PURPOSE: To test the ProTek (Vifilcon A) therapeutic soft contact lens in the alleviation of post-photorefractive keratectomy pain, its effect on epithelial healing, and its safety. METHODS:Forty-seven consecutive eligible patients undergoing unilateral excimer laser photorefractive keratectomy for myopia were randomly assigned to receive standard postoperative care with or without the use of a ProTek soft contact lens. Patients prospectively graded a self-administered 5-point scale for pain and a 4-point scale for abnormal sensations at 4, 8, 12, 16, and 20 hours after surgery. They also recorded the type and dose of all medications taken during that time period. All patients were examined on the first and third days after surgery. The lenses were worn continuously for 3 days. RESULTS: The soft contact lens group (n = 24) disclosed a statistically significant (P < .05) reduction in pain intensity and abnormal sensations that was greatest at 8, 12, 16, and 20 hours postoperatively. Compared with control patients (n = 23), the soft contact lens group showed significant decreased dependence on most pain medications after the 12th hour (P < .05) and faster epithelial healing (P = .03). However, one case of bacterial keratitis, two cases of subepithelial infiltrates, and seven cases of contact lens intolerance were present in the soft contact lens group. CONCLUSIONS: The ProTek therapeutic soft contact lenses were effective in decreasing pain and other related abnormal sensations after excimer photorefractive keratectomy. They decreased dependence on pain medications and hastened epithelial healing but were not well tolerated in some patients.
RCT Entities:
PURPOSE: To test the ProTek (Vifilcon A) therapeutic soft contact lens in the alleviation of post-photorefractive keratectomy pain, its effect on epithelial healing, and its safety. METHODS: Forty-seven consecutive eligible patients undergoing unilateral excimer laser photorefractive keratectomy for myopia were randomly assigned to receive standard postoperative care with or without the use of a ProTek soft contact lens. Patients prospectively graded a self-administered 5-point scale for pain and a 4-point scale for abnormal sensations at 4, 8, 12, 16, and 20 hours after surgery. They also recorded the type and dose of all medications taken during that time period. All patients were examined on the first and third days after surgery. The lenses were worn continuously for 3 days. RESULTS: The soft contact lens group (n = 24) disclosed a statistically significant (P < .05) reduction in pain intensity and abnormal sensations that was greatest at 8, 12, 16, and 20 hours postoperatively. Compared with control patients (n = 23), the soft contact lens group showed significant decreased dependence on most pain medications after the 12th hour (P < .05) and faster epithelial healing (P = .03). However, one case of bacterial keratitis, two cases of subepithelial infiltrates, and seven cases of contact lens intolerance were present in the soft contact lens group. CONCLUSIONS: The ProTek therapeutic soft contact lenses were effective in decreasing pain and other related abnormal sensations after excimer photorefractive keratectomy. They decreased dependence on pain medications and hastened epithelial healing but were not well tolerated in some patients.