- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07838597
The Emmetropization Via Accommodation (EVA) - II Study (EVA-II)
To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).
연구 개요
상세 설명
Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ann M Morrison, OD, PhD
- 전화번호: 614-247-0010
- 이메일: morrison.421@osu.edu
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43209
- The Ohio State University College of Optometry
-
연락하다:
- Ann M Morrison, OD, PhD
- 전화번호: 614-247-0010
- 이메일: morrison.421@osu.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Signed parental permission and HIPAA authorization and willingness to comply with study procedures.
- Infant 13-19 weeks of age at baseline.
- Either sex and any race or ethnicity.
- Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g.
- Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination.
- Cycloplegic spherical-equivalent hyperopia ≥+3.50 D in one or both eyes.
Exclusion Criteria:
- Astigmatism >2.00 D in either eye.
- Anisometropia >1.50 D spherical equivalent.
- Strabismus.
- Previous difficulty with pupil dilation.
- Cardiac, liver, asthma, or other respiratory disease.
- Ocular disease/abnormality, prior intraocular surgery, retinal detachment, optic nerve hypoplasia, malformation of the eye, cortical visual impairment, or active ocular inflammation.
- Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder.
- A condition preventing spectacle wear for the study duration (e.g., plagiocephaly).
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 |
|---|---|
|
간섭 없음: Observation
No treatment is administered in this arm. |
|
|
실험적: Spectacles and At-Home Therapy
Participants will receive experimental treatment. |
Infants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ocular Accommodation measured with MEM
기간: 14 months
|
Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM). |
14 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between refractive error and ocular accommodation measured with MEM
기간: 14 months
|
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with MEM retinoscopy, in Diopters (D) |
14 months
|
|
Correlation between refractive error and ocular accommodation measured with PowerRefractor
기간: 14 months
|
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with the PlusOptix PowerRefractor, in Diopters (D) |
14 months
|
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
마지막으로 확인됨
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. .