Efficacy and Safety of Dual-Effect Myopia Control Lenses for Slowing Myopia Progression: A Single-Center, Randomized, Controlled, Noninferiority Trial
This study aims to evaluate the efficacy and safety of dual-effect myopia control spectacle lenses in slowing myopia progression compared with Nikon MyoEase 2.0 lenses in children aged 8-13 years.
This is a single-center, randomized, open-label, parallel-group, noninferiority clinical trial. A total of 194 children with myopia will be randomly assigned in a 1:1 ratio to wear either dual-effect myopia control spectacle lenses or Nikon MyoEase 2.0 lenses for 12 months.
The primary outcome is the change in cycloplegic objective spherical equivalent refraction from baseline to 12 months. Secondary outcomes include changes in refractive error, ocular biometric parameters, visual acuity, binocular visual function, and visual questionnaire scores. Safety will also be assessed throughout the study.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 8-13 years, regardless of sex, with written consent from both the participant and their legal guardian.
- Cycloplegic objective spherical equivalent refraction between -4.75 D and -0.75 D (inclusive) in both eyes, astigmatism ≥-1.50 D, and an absolute interocular difference in spherical equivalent refraction ≤1.00 D.
- Best-corrected visual acuity ≥1.0 in both eyes.
- Intraocular pressure within the normal range (10-21 mmHg) in both eyes.
- Voluntary participation in the study with signed informed consent.
Exclusion Criteria:
- History of ocular trauma or intraocular surgery.
- Clinically abnormal slit-lamp examination findings.
- Fundus examination grade ≥2.
- Other ocular diseases, including uveitis or other ocular inflammation, glaucoma, cataract, fundus disease, ocular tumors, ocular trauma, manifest strabismus, or any ocular condition affecting visual function.
- Systemic diseases associated with immunodeficiency or conditions considered by the investigator unsuitable for spectacle wear, such as diabetes, Down syndrome, rheumatoid arthritis, or psychiatric disorders.
- Participation in a drug clinical trial within the previous 3 months or a medical device clinical trial within the previous month.
- Meeting the inclusion criteria in only one eye.
- Inability to attend regular ophthalmic examinations.
- Participation in any myopia control clinical trial within the previous 3 months, or previous or current use of rigid contact lenses (including associated care products), multifocal contact lenses, progressive addition lenses or other specially designed myopia control spectacle lenses, or atropine.
- Deemed ineligible by the investigator.
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 |
|---|---|
|
실험적: Dual-Effect Myopia Control Lenses
Participants in this group will wear dual-effect myopia control spectacle lenses for 12 months, with a recommended daily wearing time of at least 12 hours. |
Dual-effect myopia control spectacle lenses manufactured by Jiangsu Kangmeida Optical Co., Ltd. Participants will be advised to wear the spectacles for at least 12 hours per day for 12 months. |
|
활성 비교기: Nikon Kongyoudian 2.0 Lenses
Participants in this group will wear Nikon Kongyoudian 2.0 spectacle lenses for 12 months, following the same wearing instructions as the experimental group. |
Nikon Kongyoudian 2.0 spectacle lenses manufactured by Nikon Optical Co., Ltd. The lenses will be used in the same manner as the investigational lenses for 12 months. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Cycloplegic Spherical Equivalent Refraction at 12 Months
기간: Baseline and 12 months (±30 days)
|
Change in spherical equivalent refraction (SER) from baseline to 12 months, measured by objective autorefraction under cycloplegia. SER is calculated as sphere power plus half the cylinder power, expressed in diopters (D). |
Baseline and 12 months (±30 days)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Axial Length
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in axial length from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Cycloplegic Spherical Equivalent Refraction at 6 Months
기간: Baseline and 6 months (±30 days)
|
Change in spherical equivalent refraction (SER) from baseline to 6 months, measured by objective autorefraction under cycloplegia, expressed in diopters (D). |
Baseline and 6 months (±30 days)
|
|
Visual Acuity With Study Spectacles
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Visual acuity measured while wearing the assigned study spectacles. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Corneal Curvature
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in corneal curvature from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Anterior Chamber Depth
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in anterior chamber depth from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Lens Thickness
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in crystalline lens thickness from baseline, measured before cycloplegia using optical biometry. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Change in Subjective Refraction
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in subjective refraction from baseline, assessed before cycloplegia. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Best-Corrected Visual Acuity
기간: 6 months (±30 days) and 12 months (±30 days)
|
Best-corrected visual acuity assessed using an ETDRS logMAR E chart. |
6 months (±30 days) and 12 months (±30 days)
|
|
Change in Binocular Visual Function
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Change in binocular visual function from baseline, assessed at follow-up visits. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
|
Visual Questionnaire Score
기간: 6 months (±30 days) and 12 months (±30 days)
|
Visual assessment using the Chinese version of the PRER2 questionnaire. |
6 months (±30 days) and 12 months (±30 days)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Adverse Events and Serious Adverse Events
기간: Throughout the 12-month study period
|
Occurrence of symptoms, signs, complications, adverse events, and serious adverse events related to the study products or procedures. |
Throughout the 12-month study period
|
|
Intraocular Pressure
기간: 6 months (±30 days), and 12 months (±30 days)
|
Intraocular pressure measured using non-contact tonometry, expressed in mmHg. |
6 months (±30 days), and 12 months (±30 days)
|
|
Fundus Examination Grade
기간: 6 months (±30 days), and 12 months (±30 days)
|
Fundus findings assessed and graded according to the study protocol. |
6 months (±30 days), and 12 months (±30 days)
|
|
Spectacle Frame Position Assessment
기간: Baseline, 6 months (±30 days), and 12 months (±30 days)
|
Assessment of spectacle frame positioning and lens condition according to the study protocol. |
Baseline, 6 months (±30 days), and 12 months (±30 days)
|
공동 작업자 및 조사자
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
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추가 정보
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