Effect of a Myopia Control Lens on the Astigmatism in Children (MAC)
A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R&D Centre for scheduled follow-up sessions
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Thomas Boudenne
- 이메일: thomas.boudenne@essilor.com
연구 연락처 백업
- 이름: Celine Carimalo
- 전화번호: +65 67134600
- 이메일: carimalc@essilor.com.sg
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
Refractive error (manifest refraction):
- With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
- Astigmatism should be more than or equal to 1.50D
- Least myopic meridian equal or less than -0.50D
- Most myopic meridian equal or greater than -5.50D.
- Anisometropia should be less than or equal to 1.00D
- Best corrected visual acuity: Better than 0.2 logMAR in each eye
Willingness and ability to:
- participate in trial for at least 12 months.
- attend scheduled visits.
- not to be involved in other myopia control treatments concurrently.
- No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Exclusion Criteria:
History or presence of:
- An ocular disease
- Strabismus
- Amblyopia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Myopia Control Lens Prototype
Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements. Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period. |
Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change from baseline in the Cylinder value through non cycloplegic autorefraction
기간: 12 months
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in the Keratometry value measured using a Keratometer
기간: 12 months
|
12 months
|
|
|
Change from baseline in the Axial Length value measured using a biometer
기간: 12 months
|
12 months
|
|
|
Quality of Life while wearing the study lenses measured through Questionnaire
기간: Baseline, 6 and 12 months
|
PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall. The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes |
Baseline, 6 and 12 months
|
기타 결과 측정
결과 측정 |
기간 |
|---|---|
|
Safety: Change from baseline in the Axial Length value measured using a biometer
기간: 3 and 6 months
|
3 and 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Si Ying Lim, EssilorLuxottica
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
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