Myopia, Progressive
Conditions
Keywords
myopia, axial length, DIMS
Brief 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.
Interventions
DEVICEframe lens
The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
Sponsors
Tianjin Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic objective refraction | 12months | Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | 12months | Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan). |
Countries
China
Outcome results
None listed