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Inhibition of Myopia Progression With Optical Devices

2026년 7월 7일 업데이트: Barcsay-Veres Amarilla, Semmelweis University

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:

  1. How does myopia progression change with age while wearing myopia progression control glasses?
  2. 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?
  3. 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

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:

  1. How does myopia progression change with age while wearing myopia progression control glasses?
  2. 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?
  3. 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

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Budapest, 헝가리, 1085
        • 모병
        • Semmelweis University Ophthalmology Department
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Otto A Maneschg, PhD
        • 부수사관:
          • Amarilla Barcsay-Veres, PhD

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

샘플링 방법

확률 샘플

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Myopic cohort

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
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

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department

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 (실제)

2026년 6월 2일

기본 완료 (추정된)

2027년 5월 31일

연구 완료 (추정된)

2027년 5월 31일

연구 등록 날짜

최초 제출

2026년 6월 27일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

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?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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

3
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