Advanced Technology for Myopia Control in Children and Young Adults (MyopiaTech RCT)

Role of Advanced Technological Approaches for Myopia Control in Myopic Patients: A Randomized Controlled Trial of Lenslet Spectacles vs. Violet Excitation Filter Glasses vs. Single Vision Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia (Disorder); Refraction Error
• Intervention / Treatment: Device: Lenslet Spectacles; Device: Violet Excitation Filter Glasses; Device: Single Vision Lenses

Detailed Description

This is a randomized controlled trial (RCT) with three parallel groups. The study will be conducted at schools and the Universities in Faisalabad, Pakistan. The total study duration is almost one year (July 2025 to May 2026), with each participant undergoing atleast 3 months of active treatment with 3 follow up analysis. The sample size is 30 participants per group (total N=90), after drop of patients, calculated using G*Power (repeated measures ANOVA, 3 groups × 4 time points, medium effect size f=0.25, α=0.05, power=0.8). Simple random sampling will be used, with participants allocated to groups using an online research randomizer. Inclusion criteria: axial myopia (high, moderate, or severe), age 8-20 years, both genders, willingness to wear glasses. Exclusion criteria:

other ametropia, contact lens users, prior myopia treatment, ocular or systemic disease, ocular surgery, non-cooperative patients. Lenslet group: Essilor Stellest spectacles with HALT (Highly Aspheric Lenslet Target) technology, 1.6mm thickness, refractive index 1.56, UV 400nm protection, antireflective coating; worn all waking hours. Violet filter group: CR-39 glasses with 420nm violet excitation filter; worn 3 hours daily (11 AM to 2 PM) to align with circadian rhythm. Control group: single vision lenses (SVS index 1.56). Primary outcome measures: change in axial length (measured by A-SCAN biometer) and change in cycloplegic refraction. Secondary outcome measures: visual acuity (LogMAR chart), contrast sensitivity (Vistech chart). Follow-up assessments at 3, 6, and 9 months. Statistical analysis: repeated measures ANOVA using SPSS version 26 to compare within-group and between-group changes.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Faisalābad, Punjab Province, Pakistan, 3800
      • The University of Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenslet Spectacles (HALT Technology; 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; 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.
Experimental: Violet Excitation Filter Glasses; 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; 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.
Active Comparator: Single Vision Lenses; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Acuity	Visual acuity measured using LogMAR chart (Precision Vision) at distances of 4m, 2m, and 1m. LogMAR score recorded for each eye separately and both eyes together.	Baseline, Month 3, Month 6, Month 9
Change in Contrast Sensitivity	Contrast sensitivity measured using Vistech chart (Precision Vision) at 1m distance. Scores recorded for each eye separately and both eyes together.	Baseline, Month 3, Month 6, Month 9

Collaborators and Investigators

• Sponsor: University of Faisalabad

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): May 30, 2026
• Study Completion (Actual): June 6, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Myopia Control; Axial Elongation; Lenslet; Violet Excitation Filter; HALT Technology
• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: TUF/IRB/ 38 /25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No