Clinical Trials Logo
  1. Home
  2. Myopia
  3. NCT05331378

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Myopia Clinical Trial

Official title:
A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).

Clinical Trial Summary

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Clinical Trial Description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05331378
Study type Interventional
Source Essilor International
Contact
Status Active, not recruiting
Phase N/A
Start date April 25, 2022
Completion date October 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04923841 - Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine N/A
Active, not recruiting NCT04080128 - Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control N/A
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Completed NCT04604405 - Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation N/A
Recruiting NCT05594719 - The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow N/A
Completed NCT05594732 - The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow N/A
Completed NCT04492397 - Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI) N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT06046209 - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens N/A
Recruiting NCT06344572 - Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia Phase 3
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05656885 - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses N/A
Active, not recruiting NCT05534022 - Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression. N/A
Completed NCT03934788 - the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT03701516 - Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2 N/A
Completed NCT05538754 - Post-Market Evaluation of the EVO ICL N/A
Completed NCT03139201 - Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT02555722 - Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear N/A
Not yet recruiting NCT06009458 - Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear N/A
Recruiting NCT05548478 - Corneal Endothelial Cell Injury Induced by Mitomycin-C N/A