Visual performance of three myopia control spectacles for children in China

Phase 3

Completed

• Conditions: Myopia control in myopic children; Eye Diseases

• Registration Number: ISRCTN50468704
• Lead Sponsor: SightGlass Vision

Brief Summary

Abstract results see attached file ISRCTN50468704_Abstract.pdf (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Study Completion: 2023-09-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Myopic children aged 6 to 14 years, with spherical equivalent refraction (SER) -0.75 D to -4.00 D (by cycloplegic autorefraction) in each eye.
2. Best corrected visual acuity (BCVA) by manifest refraction of +0.10 logMAR (0.8 Snellen equivalent) or better in each eye.
3. Pass stereopsis and color vision screening.
4. Ability to comply with all study procedures, including assessments of visual performance with assigned correction.
5. Willingness to wear assigned spectacles for the duration of the study.
6. The subject's parent(s) or legal guardian(s) must read, understand and sign the ICF and receive a fully executed copy.

Exclusion Criteria

1. Prior use of any myopia control approaches, such as atropine, multifocal contact lenses, orthokeratology (ortho-K), or other spectacle lenses designed for myopia control including peripheral defocus, bifocal, and progressive addition lenses.
2. Astigmatism worse than -1.25 DC (by manifest refraction) in either eye.
3. Anisometropia (SER manifest refraction) greater than 1.00 D.
4. Amblyopia in either eye.
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
6. Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness).
7. Participation in any investigational clinical study within 30 days of the Screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual performance measured using Aston Vision iPad App (visual acuity, reading speed, near contrast sensitivity, and halometry) of test spectacles at baseline and after 1-2 weeks of wear in comparison with habitual spectacles.<br>1. Visual acuity in logMAR (number of letters read on the letter chart)<br>2. Reading speed in maximum words per minute<br>3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) <br>4. Halometry in halo radius in degrees

Secondary Outcome Measures

Name	Time	Method
Visual performance measured using Aston Vision iPad App at baseline and after 1-2 weeks of wear with 3 different test spectacles:<br>1. Visual acuity in logMAR (number of letters read on the letter chart)<br>2. Reading speed in maximum words per minute<br>3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) <br>4. Halometry in halo radius in degrees<br>