DIMS-myopia Progression ADN Axial Length Growth

Myopia, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300321
• Other study ID #: KY201902
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 1, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic objective refraction	Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).	12months
Secondary	Axial Length	Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).	12months