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

June 1, 2026 updated by: LAM Chuen Thomas, FAAO, PhD, The Hong Kong Polytechnic University

A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Optical strategies have been shown to be effective for slowing myopia progression. The design of the BLMCL patented spectacle lens is based on existing myopic control theory of peripheral defocus spectacle lenses. This prospective, observational cohort study aims to evaluate the short-term efficacy and safety of the BLMCL lens in school-aged children. Forty participants, aged 6 to 15 years with SER between -6.00D to -0.75D and astigmatism not more than -2.00D, will be fitted with the BLMCL Lens and followed for six months. They will be required to return for five scheduled visits: baseline, delivery, 1 month, 3 months, and 6 months after lens delivery visits. The primary endpoint is the change in subfoveal choroidal thickness (SfChT) for potential effective myopia control via SfChT thickening. The secondary endpoints are the changes in AL and refraction after cycloplegia which allow comparison with other myopia control studies. Subjective symptoms will be assessed using the PREP2 and QoV questionnaires.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BLMC lenses
Participants will be prescribed with a pair of study spectacle lenses for six months
Other: BCMC lens
BLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subfoveal choroidal thickness (SfChT)
Time Frame: Delivery and 1, 3, and 6 months after delivery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260302008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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