DIMS-myopia Progression ADN Axial Length Growth

Tianjin Eye Hospital

Status: Completed

Conditions: Myopia, Progressive

Treatments: Device: frame lens

Study type: Interventional

Funder types: Other

Identifiers

NCT05300321

KY201902

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

82 participants in 2 patient groups

Single Vision Lens

Experimental group

Description:

The sunbjects were randomized to allocate in single vision lens group.

Treatment:

Device: frame lens

Defocus Incorporated Multiple Segments (DIMS) Lens

Experimental group

Description:

The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group.

Treatment:

Device: frame lens