Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children

Tianjin Eye Hospital1 site in 1 country82 target enrollmentJune 1, 2019

ConditionsMyopia, Progressive

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia, Progressive
Sponsor: Tianjin Eye Hospital
Enrollment: 82
Locations: 1
Primary Endpoint: Cycloplegic objective refraction
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.

Detailed Description

The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens. The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent. We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit. Either the VA with the current spectacles dropped to \< 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

April 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Eye Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D
•Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

Exclusion Criteria

•Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.