Qi Tan1, Alex Lk Ng2,3, George Pm Cheng4, Victor Cp Woo2,3, Pauline Cho1. 1. a School of Optometry , The Hong Kong Polytechnic University , Hung Hom , Hong Kong. 2. b Department of Ophthalmology , The University of Hong Kong , Hong Kong. 3. c Hong Kong Ophthalmic Associates , Hong Kong. 4. d Hong Kong Laser Eye Centre , Hong Kong.
Abstract
Purpose: The purpose of this study is to present the study design and one month's preliminary results of a 2-year randomized trial, Combined Atropine with Orthokeratology (AOK), for myopia control study. Methods:Children aged 6 to <11 years and with 1.00-4.00 D myopia were randomly assigned to AOK group or ortho-k alone (OK) group. Subjects are required to attend routine ortho-k aftercare visits (first-overnight, 1 week, 2 weeks, 3 weeks, 1 month, and every 3 months after commencement of lens wear). Clinical outcomes, including lens performance, changes in refractive error, unaided vision, ocular adverse events, corneal staining, lens binding and centration, and axial length, are also assessed at 6-monthly data collection visit. Results: Data of 30 AOK and 34 OK subjects who had completed the 1-month visit were analyzed. No significant differences in baseline data were found between the two groups (P > 0.05). At the 1-month visit, first-fit success rate was 95%, with full myopia reduction. Mild corneal staining was observed in 23.3% and 30.9% and mild self-reported lens binding in 50% and 41% in AOK and OK groups, respectively, after 1-month lens wear. Mean (±standard deviation) change in axial length was significantly higher in AOK than OK subjects (AOK: -0.05 ± 0.05 mm; OK: -0.02 ± 0.03 mm) (P = 0.003). Conclusions: After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses. These results provide the assurance that it is acceptable to continue this longitudinal study, as longer study duration, usually 2 years, is required to determine the effectiveness of treatment for myopia control.
RCT Entities:
Purpose: The purpose of this study is to present the study design and one month's preliminary results of a 2-year randomized trial, Combined Atropine with Orthokeratology (AOK), for myopia control study. Methods:Children aged 6 to <11 years and with 1.00-4.00 D myopia were randomly assigned to AOK group or ortho-k alone (OK) group. Subjects are required to attend routine ortho-k aftercare visits (first-overnight, 1 week, 2 weeks, 3 weeks, 1 month, and every 3 months after commencement of lens wear). Clinical outcomes, including lens performance, changes in refractive error, unaided vision, ocular adverse events, corneal staining, lens binding and centration, and axial length, are also assessed at 6-monthly data collection visit. Results: Data of 30 AOK and 34 OK subjects who had completed the 1-month visit were analyzed. No significant differences in baseline data were found between the two groups (P > 0.05). At the 1-month visit, first-fit success rate was 95%, with full myopia reduction. Mild corneal staining was observed in 23.3% and 30.9% and mild self-reported lens binding in 50% and 41% in AOK and OK groups, respectively, after 1-month lens wear. Mean (±standard deviation) change in axial length was significantly higher in AOK than OK subjects (AOK: -0.05 ± 0.05 mm; OK: -0.02 ± 0.03 mm) (P = 0.003). Conclusions: After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses. These results provide the assurance that it is acceptable to continue this longitudinal study, as longer study duration, usually 2 years, is required to determine the effectiveness of treatment for myopia control.
Authors: Jeffrey J Walline; Kristina B Lindsley; S Swaroop Vedula; Susan A Cotter; Donald O Mutti; Sueko M Ng; J Daniel Twelker Journal: Cochrane Database Syst Rev Date: 2020-01-13
Authors: Monica Jong; Jost B Jonas; James S Wolffsohn; David A Berntsen; Pauline Cho; Danielle Clarkson-Townsend; Daniel I Flitcroft; Kate L Gifford; Annechien E G Haarman; Machelle T Pardue; Kathryn Richdale; Padmaja Sankaridurg; Milly S Tedja; Christine F Wildsoet; Joan E Bailey-Wilson; Jeremy A Guggenheim; Christopher J Hammond; Jaakko Kaprio; Stuart MacGregor; David A Mackey; Anthony M Musolf; Caroline C W Klaver; Virginie J M Verhoeven; Veronique Vitart; Earl L Smith Journal: Invest Ophthalmol Vis Sci Date: 2021-04-28 Impact factor: 4.799