- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07698977
Inhibition of Myopia Progression With Optical Devices
This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population.
The study aims to answer the following questions:
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement
In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.
연구 개요
상태
정황
상세 설명
As an observational study we aim to examine the effects of D.I.M.S. lens's daily wear on myopia progression in relation to the environmental factors.
Our pediatric and adolescent myopic population is selected as follows:
Inclusion Criteria:
- Participants must be between 6 and 15 years of age at the start of myopia progression treatment
- Caucasian ethnicity
- Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
- Wearing myopia-control glasses during waking hours
- Willing to Participate in follow-up examinations up to 24 weeks
Exclusion criteria:
- pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
- preterm infants born before 32 weeks of gestation
- previous eye-opening surgery (e.g., lens extraction)
- Traumatic eye injury
- Known connective tissue disorder (e.g., Marfan syndrome)
- Irregular or improper use of progressive-lens glasses
- Failure to attend the follow-up examinations scheduled
In the self-controlled observational study the myopic participants are wearing during day time DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. DIMS glasses not only correct the refractive errror but also provide a circular defocus zone to avoid periferial retinal defocus.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time, subjective symptoms.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement These measurements and tests are part of the regular ophthalmological follow-up examinations.
The study aims to answer the following questions:
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? Statistical analysis plan includes non-parametric t-test, one way and two way ANOVA tests.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Zoltan Zs Nagy, Professor
- 전화번호: +3614591500
- 이메일: szem.titkarsag@gmail.com
연구 연락처 백업
- 이름: Amarilla Barcsay-Veres
- 전화번호: +3614591500
- 이메일: veres.amarilla@semmelweis.hu
연구 장소
-
-
-
Budapest, 헝가리, 1085
- 모병
- Semmelweis University Ophthalmology Department
-
연락하다:
- Zoltan Zs Nagy, Professor
- 전화번호: +3614591500
- 이메일: szem.titkarsag@semmelweis.hu
-
연락하다:
- Amarilla Barcsay-Veres, PhD
- 전화번호: +3614591500
- 이메일: veres.amarilla@semmelweis.hu
-
부수사관:
- Otto A Maneschg, PhD
-
부수사관:
- Amarilla Barcsay-Veres, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Participants (between 6 and 15 years of age) are wearing myopia progression treatment , namely D.I.M.S. lenses while they are awake. The wear these glasses to correct refractive error and to slow down myopia progression.
At enrollment the refractive error measured under cycloplegia, expressed as spherical equivalent must be: between -0.50 Dsph and -10.0 Dsph.
설명
Inclusion Criteria:
• Participants must be between 6 and 15 years of age at the start of myopia progression treatment
- Caucasian ethnicity
- Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
- Wearing myopia-control glasses while awake
- Participation in follow-up examinations every 6 months
Exclusion Criteria:
• Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
- Premature birth before the 32nd week of gestation
- Previous eye-opening surgery (e.g., lens removal)
- Traumatic eye injury
- Known connective tissue disorder (e.g., Marfan syndrome)
- Irregular or improper use of progressive-lens glasses
- Failure to attend the follow-up examinations scheduled every 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Myopic cohort
Inclusion Criteria:
Exclusion criteria:
|
DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
D.I.M.S. lenses are worn like normal glasses to correct myopia and, beyond that, their special design is intended to slow myopia progression via defocus lenslets.
There is targeted myopic defocus produced by the mid-peripheral lenslets with positive power to inhibit eye length growth.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Best corrected visual acuity test
기간: up to 24 week
|
Zero is equivalent to no vision and 1.0 indicates the best visual acuity in decimal scale.
Distance and near visual acuity is measured under standard conditions
|
up to 24 week
|
|
Bulbar axial length measurement
기간: up to 24 week
|
It is defined as the distance from the anterior surface of the cornea to the retinal pigment epithelium, measured in millimeters using optical device.
An increase in axial length is characteristic of the elongation of the eye.
|
up to 24 week
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Stereopsis
기간: up to 24 week
|
stereopsis test (depth perception test) measures how well the eyes create three-dimensional vision.
The precision of depth perception is measured in seconds of arc (arcsec) using a test plate.
If stereoscopic vision is present, the smaller the angle, the more refined the stereopsis.
|
up to 24 week
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- SE-RKEB 222/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
근시에 대한 임상 시험
-
Tianjin Medical University Eye Hospital아직 모집하지 않음진행성 근시 | 소아 근시 | Orthokeratology-related Myopia Progression