Abstract
Purpose :
A catenary power profile lens design that delivers up to +8D Add has previously demonstrated effectiveness for myopia progression control in multiple real-world studies. PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT) is a multinational, double-masked, randomized controlled trial (RCT) evaluating the effectiveness and safety of this commercially available daily disposable soft multifocal lenses for myopia progression control in children.
Methods :
Children from 7 to <13 with cycloplegic autorefraction (CSER) between -0.75D and -5.00D were recruited from 8 clinical sites in Canada, the US, Hong Kong and Singapore. Subjects were randomized into two study groups: single vision contact lenses (SV) and catenary multifocal (MF) lenses, in a 1:2 ratio, respectively. The primary effectiveness outcome measure is the change of CSER and secondary outcome measures are the change of axial length measurement (AXL) and proportional analysis of the change of CSER. Safety measures are LogMAR Visual Acuity (VA) and Adverse Events (AE).
Results :
145 children with age (Avg±SD) 9.9±1.5 had baseline CSER -2.4±1.3 and AXL 24.5±0.8. There was no statistical difference (p>0.05) between the two groups. At 12 months, subjects’ VA is similar between groups (SV -0.04±0.08, MF -0.04±0.06 p>0.05). There were no device-related serious AEs and no difference in the rate of AEs between the groups. Subgroup analysis based on FDA-approved initial age and myopia treatment range (age from 8 to <13, and CSER between -0.75D to -4D) for myopia control using SCL MF, demonstrated an average reduction of CSER progression of 0.40D (69%) and AXL elongation reduction of 0.17mm (59%). There was a significant difference (p<0.05) in proportion between MF (42%) and SV (8%) who had ≤ 0D CSER change in 1 year.
Conclusions :
The highly aspheric catenary power profile contact lenses are safe and effective in reducing myopia progression and excessive axial elongation for children compared to the single vision control group at 12-month. These RCT results corroborate multiple real-world retrospective data indicating its robustness in myopia control ability under different clinical settings.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.