N/A
Completed N=248
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
Source: ClinicalTrials.gov NCT04080128 ↗Enrolled (actual)
248
Serious AEs
2.0%
Results posted
May 2026
Primary outcomePrimary: The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length — 0.18 mm axial length — p=<0.001
Summary
This project intends to provide important, previously unmet answers regarding biological associations with myopia (nearsightedness) progression in order to improve the ability to predict patients who are most likely to benefit from myopia control, as well as questions frequently posed by patients and practitioners about the side effects, mechanism, and discontinuation of soft bifocal contact lens myopia control. The first three aims examine the association between biological variables that can be measured non-invasively and myopia progression, and they will be conducted regardless of the outcome of the currently in progress BLINK Study. The last three specific aims will be conducted if soft bifocal contact lenses slowed myopia progression by 30% or more in the BLINK Study, and they can be investigated with very few additional measurements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Statistical Correlation Between Three-year Change in Choroidal Thickness and Three-year Change in Axial Length |
0.18 | <0.001 sig |
| PRIMARY The Statistical Correlation Between iPRGC Activity at BLINK2 Baseline and Three-year Change in Axial Length |
0.18 | 0.04 sig |
| PRIMARY The Statistical Correlation Between Light Levels Measured at Baseline and Three-year Change in Axial Length |
0.18 | 0.04 sig |
| PRIMARY Three-year Choroidal Thickness Change |
6.12 | — |
| PRIMARY Duration of Exposure to Light Levels Exceeding 1000 Lux at Baseline |
51.28 | — |
| PRIMARY Baseline iPRGC Activity |
-0.13 | — |
| SECONDARY Accommodative Amplitude |
5.72; 5.41; 5.76 | 0.49 |
| SECONDARY Lag of Accommodation |
1.69; 1.77; 1.63 | 0.41 |
| SECONDARY Accommodative Facility |
9.46; 9.17; 9.51 | 0.87 |
| SECONDARY Slowing of Myopia Progression - Axial Length |
24.95; 25.33; 25.28 | 0.054 |
| SECONDARY Rebound of Progression - Axial Length |
0.03 | 0.003 sig |
| SECONDARY Rebound of Progression - Myopia Progression |
-0.17 | <0.001 sig |
| SECONDARY Slowing of Myopia Progression - Myopia Progression |
-3.15; -3.89; -3.87 | 0.16 |
Eligibility Criteria
Inclusion Criteria
- Participants in the BLINK Study
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT04080128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.