Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children (EVASION)
2026년 7월 2일 업데이트: Essilor International
Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children
The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and < 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?
Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?
Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.
Participants will:
- Wear the study spectacles for 2 weeks
- Respond to questionnaires 4 days after dispensing and at 2 weeks
- Visit Essilor R&D Centre for screening, dispensing and follow up sessions
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Celine Carimalo
- 전화번호: +65 67134617
- 이메일: carimalc@essilor.com.sg
연구 연락처 백업
- 이름: Thomas Boudenne
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Volunteer participant who is willing and able to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
- Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
Exclusion Criteria:
- History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
- Participation in any clinical study within 30 days of the Baseline visit.
- Sibling of existing participant of this study
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Test
Test Lens
|
Dispense to Test group for 2 weeks
|
|
활성 비교기: Control
Control Lens
|
Dispense to Control group for 2 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful Adaptation Rate Within 1 Week After Dispensing
기간: Within 1 week post dispensing
|
Proportion of children who meet all of the following criteria at the 1-week visit:
Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin. |
Within 1 week post dispensing
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful Adaptation Rates at Early and Later Timepoints
기간: 4 days and 2 weeks post-dispensing
|
Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:
Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints. |
4 days and 2 weeks post-dispensing
|
|
Average daily and weekly wearing time
기간: Assessed at Day 4 and Week 2 post-dispensing
|
Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time.
|
Assessed at Day 4 and Week 2 post-dispensing
|
|
Activity-specific visual comfort
기간: 4 days and 2 weeks post-dispensing
|
Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child).
Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree).
Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned.
The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities).
Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
|
4 days and 2 weeks post-dispensing
|
|
Overall satisfaction
기간: 4 days and 2 weeks post-dispensing
|
Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child).
Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree).
Negatively worded items are reverse-coded during data analysis.
Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles).
Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
|
4 days and 2 weeks post-dispensing
|
|
High-contrast visual acuity (distance and near)
기간: At dispensing (baseline) and 2 weeks post-dispensing
|
Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups.
|
At dispensing (baseline) and 2 weeks post-dispensing
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sheron Quak, Essilor R&D Centre Singapore
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2026년 11월 1일
연구 등록 날짜
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .