Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children

NCT07511387 | Not Yet Recruiting

• 1 other identifier: 20260302008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.

Conditions

Myopia

Keywords

Myopia; Children; Myopia control; Spectacle lenses

Outcome Measures

Primary Outcomes (1)

• Change in subfoveal choroidal thickness (SfChT)

  SfChT will be measured using Swept-Source OCT (SS-OCT) without cycloplegia. It will be measured at the delivery visit before dispensing, and 1, 3 and 6 months after delivery. In order to minimize the effect of diurnal variation, it will be measured within two hours hours from the first measurement at the delivery visit. Two good quality images will be captured for each eye. Segmentation of the images will be performed by a masked examiner. Changes in SfChT after using the lenses for 1, 3, and 6 months will be determined.

  Delivery and 1, 3, and 6 months after delivery

Study Arms (1)

BLMC lenses

EXPERIMENTAL

Participants will be prescribed with a pair of study spectacle lenses for six months

Other: BCMC lens

Interventions

BCMC lens OTHER

BLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region

BLMC lenses

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 to 15 years (Chinese), inclusive
• Cycloplegic SER between -0.75 D and -6.00 D in both eyes
• Astigmatism ≤ 2.00 D in both eyes
• Anisometropia ≤ 1.50 D
• BCVA of 0.04 logMAR or better in each eye

You may not qualify if:

• Previous or current use of any myopia control intervention within 6 months
• Presence of any ocular pathology, amblyopia, colour vision deficiency or strabismus that could affect refractive development or visual function
• History of ocular surgery or significant ocular trauma
• Known systemic diseases or use of medications that could affect vision or ocular growth

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

HK (1)