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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Faisalābad, Punjab Province, 파키스탄, 3800
- The University of Faisalabad
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Axial Length
기간: Baseline, Month 3, Month 6, Month 9
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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.
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Baseline, Month 3, Month 6, Month 9
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Change in Cycloplegic Refraction
기간: Baseline, Month 3, Month 6, Month 9
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Cycloplegic refraction (diopters) measured using retinoscope (Welch Allyn) after administration of cycloplegic drops.
Spherical equivalent is calculated as sphere + (cylinder/2).
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Baseline, Month 3, Month 6, Month 9
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Visual Acuity
기간: Baseline, Month 3, Month 6, Month 9
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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.
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Baseline, Month 3, Month 6, Month 9
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Change in Contrast Sensitivity
기간: Baseline, Month 3, Month 6, Month 9
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Contrast sensitivity measured using Vistech chart (Precision Vision) at 1m distance.
Scores recorded for each eye separately and both eyes together.
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Baseline, Month 3, Month 6, Month 9
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TUF/IRB/ 38 /25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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근시(장애)에 대한 임상 시험
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Tianjin Medical University Eye Hospital아직 모집하지 않음진행성 근시 | 소아 근시 | Orthokeratology-related Myopia Progression