DIMS-myopia Progression ADN Axial Length Growth

Not Applicable

Completed

• Conditions: Myopia, Progressive
• Interventions: Device: frame lens

• Registration Number: NCT05300321
• Lead Sponsor: Tianjin Eye Hospital

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-11-30
• Study Completion: 2021-04-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Defocus Incorporated Multiple Segments (DIMS) Lens	frame lens	The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group.
Single Vision Lens	frame lens	The sunbjects were randomized to allocate in single vision lens group.

Primary Outcome Measures

Name	Time	Method
Cycloplegic objective refraction	12months	Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).

Secondary Outcome Measures

Name	Time	Method
Axial Length	12months	Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China