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OpenTrials
Completed

NCT Number: NCT05300321

DIMS-myopia Progression ADN Axial Length Growth

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

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Eye Hospital

Tianjin, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

frame lens

Device

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

Primary outcomes

  1. Cycloplegic objective refraction

    Time frame: 12months

    Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).

Secondary outcomes

  1. Axial Length

    Time frame: 12months

    Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 29, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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