Chang Rae Rho1, Chitra Pandey2, Su Young Kim3, Man Soo Kim4. 1. Department of Ophthalmology and Visual Science, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 2. Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 3. Department of Ophthalmology and Visual Science, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 4. Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: mskim@catholic.ac.kr.
Abstract
PURPOSE: To investigate the efficacy and safety of a fenestrated and channelled soft contact lens (F-SCL) compared to a standard and non-fenestrated soft contact lens (S-SCL) in experienced soft contact lens (SCL) wearers. METHODS: This was a randomised, crossover, single-blinded (subject), and multicentre clinical trial. Sixteen experienced SCL wearers were randomly divided into two groups (FS and SF). The FS group first wore F-SCLs followed by S-SCLs, each for 10 days, separated by a 1-week washout period, whereas the SF group wore the S-SCLs first and crossed over to F-SCLs in the same manner. The F-SCLs were designed with three equally spaced, symmetrical fenestrations and a partial-thickness, connecting, circumferential channel on the back surface of the mid-periphery of the lens. Measurement of central corneal thickness using ultrasonic pachymetry was performed on the day of screening, after the 1-week washout period, and after 10 days of wearing each kind of lens, based on which central corneal swelling was calculated and compared. One eye in each subject was chosen at random for analysis. RESULTS:Central corneal swelling was 1.92±1.73% vs. 5.26±2.14% in F-SCLs vs. S-SCLs wearers, which was statistically significant (P<0.001). There was no significant difference between the groups in terms of SCL-corrected visual acuity or SCL-related adverse events. CONCLUSION: The use of F-SCLs led to reduced corneal swelling compared to S-SCLs. The newly incorporated features appear to improve tear mixing and thereby the oxygen supply to the cornea, which results in reduced corneal oedema.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of a fenestrated and channelled soft contact lens (F-SCL) compared to a standard and non-fenestrated soft contact lens (S-SCL) in experienced soft contact lens (SCL) wearers. METHODS: This was a randomised, crossover, single-blinded (subject), and multicentre clinical trial. Sixteen experienced SCL wearers were randomly divided into two groups (FS and SF). The FS group first wore F-SCLs followed by S-SCLs, each for 10 days, separated by a 1-week washout period, whereas the SF group wore the S-SCLs first and crossed over to F-SCLs in the same manner. The F-SCLs were designed with three equally spaced, symmetrical fenestrations and a partial-thickness, connecting, circumferential channel on the back surface of the mid-periphery of the lens. Measurement of central corneal thickness using ultrasonic pachymetry was performed on the day of screening, after the 1-week washout period, and after 10 days of wearing each kind of lens, based on which central corneal swelling was calculated and compared. One eye in each subject was chosen at random for analysis. RESULTS: Central corneal swelling was 1.92±1.73% vs. 5.26±2.14% in F-SCLs vs. S-SCLs wearers, which was statistically significant (P<0.001). There was no significant difference between the groups in terms of SCL-corrected visual acuity or SCL-related adverse events. CONCLUSION: The use of F-SCLs led to reduced corneal swelling compared to S-SCLs. The newly incorporated features appear to improve tear mixing and thereby the oxygen supply to the cornea, which results in reduced corneal oedema.