Advanced Technology for Myopia Control in Children and Young Adults

NCT07645183 | Completed

• 1 other identifier: TUF/IRB/ 38 /25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Myopia, or nearsightedness, is increasing rapidly worldwide, especially in children and young adults. This study will test two advanced treatments for slowing myopia progression with one control group: special lenslet spectacles (Stellest with HALT technology) and violet excitation filter glasses (wavelength 420 nm) and Single vision lenses for controls. The study will enroll 90 participants aged 8 to 20 years from schools and universities in Faisalabad, Pakistan. Participants will be randomly assigned to one of three groups: lenslet spectacles, violet filter glasses, or single vision lenses (control group). Visual acuity, contrast sensitivity, Spherical Equivalent and axial length will be measured at the start and again after 3, 6, and 9 months and one follow up after cessation of treatment. The study aims to determine whether these advanced technologies can effectively slow myopia progression compared to standard glasses, providing head-to-head evidence on emerging and established optical interventions for myopia control.

Conditions

Myopia (Disorder); Refraction Error

Keywords

Axial Elongation; Lenslet; Violet Excitation Filter; HALT Technology; Myopia Control

Outcome Measures

Primary Outcomes (2)

• Change in Axial Length

  Axial length (mm) measured using A-SCAN biometer (Scanmate 677AB model). Measurement is taken from the corneal apex to the retinal pigment epithelium. Three measurements are taken for each eye, and the average is recorded.

  Baseline, Month 3, Month 6, Month 9

• Change in Cycloplegic Refraction

  Cycloplegic refraction (diopters) measured using retinoscope (Welch Allyn) after administration of cycloplegic drops. Spherical equivalent is calculated as sphere + (cylinder/2).

  Baseline, Month 3, Month 6, Month 9

Secondary Outcomes (2)

• Change in Visual Acuity

  Baseline, Month 3, Month 6, Month 9

• Change in Contrast Sensitivity

  Baseline, Month 3, Month 6, Month 9

Study Arms (3)

Lenslet Spectacles (HALT Technology

EXPERIMENTAL

Participants receive Essilor Stellest spectacle lenses featuring HALT (Highly Aspheric Lenslet Target) anf violet filter glasses technology. Lenses have 1.6mm thickness, refractive index 1.56, UV 400. Participants are instructed to wear glasses throughout all waking hours for 9 months and for VF atleast 3ours.

Device: Lenslet Spectacles

Violet Excitation Filter Glasses

EXPERIMENTAL

Participants receive prescription glasses with violet excitation filter (420 nm wavelength, CR-39 material). Participants are instructed to wear glasses for 3 hours daily (11 AM to 2 PM) for 12 months to align with circadian rhythm.

Device: Violet Excitation Filter Glasses

Single Vision Lenses

ACTIVE COMPARATOR

Participants receive standard single vision spectacle lenses (SVS index 1.56). Participants are instructed to wear glasses throughout all waking hours for 12 months.

Device: Single Vision Lenses

Interventions

Lenslet Spectacles DEVICE

The lenslet spectacles are specially designed spectacle lenses featuring HALT (Highly Aspheric Lenslet Target) technology manufactured by Essilor International (Serial Number: 72426930). The lens design includes a clear distance zone in the center with peripheral areas providing single vision correction. Technical specifications: 5H green covering, multi-dimensional pattern, 1.6mm thickness, refractive index 1.56, UV 400nm protection, antireflective coating. Participants are instructed to wear the spectacles throughout all waking hours. Each participant receives a new pair at baseline. No adjustments are made during the 12-month treatment period unless vision changes require prescription update.

Lenslet Spectacles (HALT Technology

Violet Excitation Filter Glasses DEVICE

The violet excitation filter glasses are prescription glasses incorporating a violet light filter with wavelength 420 nm (range 360-420 nm). Material: CR-39. Filter intensity: 700 nm. Wavelength verified using spectrophotometer (standard error ±0.1 to 1 nm). Participants are instructed to wear the glasses for 3 hours daily, specifically from 11 AM to 2 PM, to optimize impact on circadian rhythm while avoiding disruption of sleep patterns. Each participant receives a new pair at baseline. The filter is integrated into the prescription lenses.

Violet Excitation Filter Glasses

Single Vision Lenses DEVICE

Standard single vision spectacle lenses (SVS index 1.56) with no myopia control features. These are conventional prescription glasses that correct refractive error but do not incorporate lenslet technology or violet filtering. Participants are instructed to wear the glasses throughout all waking hours. Each participant receives a new pair at baseline.

Single Vision Lenses

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of axial myopia (high, moderate, or severe)
• Age between 8 and 20 years (inclusive)
• Male or female
• Willingness to wear prescribed glasses as instructed
• Willingness to attend all follow-up visits (3, 6, and 9 months)
• Written informed consent from participant or parent/guardian for minors

You may not qualify if:

• Any ametropia other than axial myopia (e.g., hyperopia, astigmatism \>1.50D)
• Current contact lens users
• Prior or concurrent myopia treatment other than study interventions
• Any ocular disease (e.g., cataract, glaucoma, retinal disorders)
• Any systemic disease affecting vision (e.g., diabetes, Marfan syndrome)
• History of any ocular surgery
• Allergic or physical intolerance to glasses materials
• Non-cooperative patients unwilling to comply with study procedures

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Optometry

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: July 1, 2025
• Primary Completion: May 30, 2026
• Study Completion: June 6, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)