Assessment of optical quality of myopia control spectacle lenses
| ISRCTN | ISRCTN63322466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63322466 |
| Sponsor | SightGlass Vision, Inc. (United States) |
| Funder | SightGlass Vision |
- Submission date
- 03/11/2026
- Registration date
- 10/11/2026
- Last edited
- 10/11/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Giancarlo Montani
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
Piazza Tancredi, 7
Lecce
73100
Italy
| Phone | +39 (0)377 182 5055 |
|---|---|
| giancarlo.montani@unisalento.it |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Crossover |
| Purpose | Treatment |
| Scientific title | Objective and subjective assessment of optical quality and light scattering induced by myopia-control spectacle lens treatment zones |
| Study objectives | To quantify the optical and perceptual impact of central and treatment-zone designs in myopia-control spectacle lenses. |
| Ethics approval(s) |
Approved 16/09/2026, Ethics Committee of the Department of Mathematics and Physics at the University of Salento (Piazza Tancredi, 7, Lecce, 73100, Italy; +39 (0)377 182 5055; maurizio.martino@unisalento.it), ref: ECDMP-2026-09-0016 |
| Health condition(s) or problem(s) studied | Myopia |
| Intervention | A within-subject, repeated-measures design will be used, with each participant undergoing all test-lens conditions. The order of lens designs, including the single-vision control lens, will be randomized for each participant using a computer-generated sequence. For myopia-control lenses, the order of central optical-zone and treatment-zone testing will also be randomized. Only one eye per participant will be included. The dominant eye will be selected as the study eye; if ocular dominance cannot be established, the study eye will be randomly selected. This study compares several eyeglass lenses designed to help manage myopia with a standard single-vision lens: 1. Defocus segments 2. Aspheric lenslets 3. Cylindrical Annular Refractive Element 4. Micro Optical Variable Elements 5. Diffusion Optics Technology Duration: Two visits, each visit will last approximately 1 hour. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Myopia control spectacle lenses |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/07/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 22 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Age between 18 and 22 years, inclusive 2. Manifest spherical equivalent refraction between −0.50 and 0.00 D, inclusive, in the study eye 3. Refractive astigmatism of less than 0.50 D in magnitude in the study eye 4. Best-corrected high-contrast visual acuity better than 0.00 logMAR in the study eye 5. Ability to understand and complete the study procedures and provide written informed consent |
| Key exclusion criteria | 1. Failure to meet any of the inclusion criteria 2. Any ocular disease or abnormality that could affect visual acuity, optical quality, or intraocular straylight 3. Previous ocular surgery or ocular trauma that could influence the study measurements 4. Use of ocular or systemic medications that could affect visual function, pupil size, or the ocular surface 5. Inability to complete the measurements reliably or comply with the study procedures |
| Date of first enrolment | 20/10/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Italy
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
09/11/2026: Study's existence confirmed by the Ethics Committee of the Department of Mathematics and Physics at the University of Salento.
