Myopia
Conditions
Brief summary
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Detailed description
A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens will be 3 years including a total of 5 visits. The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups: * Control group who will receive standard monofocal lenses. * Treatment group who will wear a prototype lens based on peripheral positive defocus.
Interventions
OTHERMyopia control lens
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Sponsors
Universidad Europea de Madrid
Indizen Optical Technologies, S.L.U.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 5 to 12 years old * Myopia (spherical equivalent with cycloplegic) ≤ -0.50D * Astigmatism \< 1.50D * Anisometropia \< 1.50D * Best-corrected visual acuity ≥ 20/20
Exclusion criteria
* Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses. * Participants with ocular pathology such as retinal detachment. * Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface. * Participants with systemic diseases that may affect vision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Lenght Increase | 5 minutes | Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group The control group consisted of 34 children using standard spherocylindrical lenses. | 34 |
| Treatment Group The treatment group included 35 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens. | 35 |
| Total | 69 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 9.6 years STANDARD_DEVIATION 1.8 | 10.4 years STANDARD_DEVIATION 1.8 | 10.0 years STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Spanish children | 34 participants | 35 participants | 69 participants |
| Sex: Female, Male Female | 17 Participants | 23 Participants | 40 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Axial Lenght Increase
Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myopia Control Lens | Axial Lenght Increase | 0.27 mm | Standard Deviation 0.23 |
| Treatment Group | Axial Lenght Increase | 0.37 mm | Standard Deviation 0.24 |