DIMS-myopia Progression ADN Axial Length Growth
Study Details
Study Description
Brief Summary
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Vision Lens The sunbjects were randomized to allocate in single vision lens group. |
Device: frame lens
The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
|
| Experimental: Defocus Incorporated Multiple Segments (DIMS) Lens The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group. |
Device: frame lens
The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
|
Outcome Measures
Primary Outcome Measures
- Cycloplegic objective refraction [12months]
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).
Secondary Outcome Measures
- Axial Length [12months]
Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Eye Hospital | Tianjin | China |
Sponsors and Collaborators
- Tianjin Eye Hospital
Investigators
- Principal Investigator: Xiaoqin Chen, MD, Tianjin Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY201902