NCT05300321

DIMS-myopia Progression ADN Axial Length Growth

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	frame lens	The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-11-30
• Completion: 2021-04-01
• First posted: 2022-03-29
• Last updated: 2022-04-25

Locations

1 site across 1 country: China