- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07697131
A Comparative Study of Fusional Vergence According to Ocular Dominance in Healthy Subjects (ECAFOSS)
In orthoptics, fusional vergence (FV) measurement is one of the key tests used to assess fusion ability. These amplitudes are generally reduced in individuals with convergence insufficiency. Fusional vergence are quantified by placing a prism bar randomly in front of one eye-first for distance vision and then for near vision. Rehabilitation exercises using the prism bar are also performed in the same manner.
Depending on orthoptic practice, the prism bar is placed in front of the left eye or the right eye, in a dogmatic manner, or in front of the right eye, in a conventional manner, without any study providing any justification. However, some practitioners report interocular differences when measuring fusion amplitudes depending on which eye is prismed, while others do not.
The hypothesis put forward is that, in individuals with an interocular difference in fusional vergence, ocular dominance (sensory and motor) could be the cause of this measurement discrepancy.
The objective is therefore to compare the difference in fusional vergence depending on whether the dominant or non-dominant eye is tested, using a randomized order of eyes and tests.
If this hypothesis is confirmed (greater fusional vergence when tested on the dominant eye), this would: (1) enhance our understanding of fusion mechanisms, (2) provide more targeted insights for the assessment, quantification, and rehabilitation of fusional vergence to improve the effectiveness of orthoptic intervention.
연구 개요
상태
정황
상세 설명
In orthoptics, fusional vergence (FV) measurement is one of the key tests used to assess fusion ability. These amplitudes are generally reduced in individuals with convergence insufficiency. Fusional vergence are quantified by placing a prism bar randomly in front of one eye-first for distance vision and then for near vision. Rehabilitation exercises using the prism bar are also performed in the same manner.
Depending on orthoptic practice, the prism bar is placed in front of the left eye or the right eye, in a dogmatic manner, or in front of the right eye, in a conventional manner, without any study providing any justification. However, some practitioners report interocular differences when measuring fusion amplitudes depending on which eye is prismed, while others do not.
The hypothesis put forward is that, in individuals with an interocular difference in fusional vergence, ocular dominance (sensory and motor) could be the cause of this measurement discrepancy.
The objective is therefore to compare the difference in fusional vergence depending on whether the dominant or non-dominant eye is tested, using a randomized order of eyes and tests.
If this hypothesis is confirmed (greater fusional vergence when tested on the dominant eye), this would: (1) enhance our understanding of fusion mechanisms, (2) provide more targeted insights for the assessment, quantification, and rehabilitation of fusional vergence to improve the effectiveness of orthoptic intervention.
The study consists of one-hour eye examinations of healthy individuals with no visual or oculomotor disorders.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Maxence Rateaux, PhD
- 전화번호: +33 01 44 49 53 62
- 이메일: maxence.rateaux@aphp.fr
연구 연락처 백업
- 이름: Hélène Morel
- 전화번호: +33 01 44 38 16 53
- 이메일: helene.morel@aphp.fr
연구 장소
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Paris, 프랑스, 75015
- Hôpital Necker-Enfants Malades
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연락하다:
- Maxence Rateaux, PhD
- 전화번호: +33 01 44 49 53 62
- 이메일: maxence.rateaux@aphp.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults between the ages of 18 and 35 with no known eye conditions, with or without ametropia. If ametropia is present: it must be corrected
- Subjects with no history of eye surgery, including refractive surgery
- Subjects who have been informed about the study and have freely and knowingly consented to participate in the study and to the collection of data
Exclusion Criteria:
- Subjects with strabismus
- Subjects with visual acuity of less than 20/20; or anisometropia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Healthy individual
Individuals with no visual or oculomotor disorders.
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Measurement of sensorimotor fusional vergence in the right and left eyes, in divergence and convergence, first for distance vision and then for near vision.
A random draw will determine which eye is tested first for distance vision, followed by a second draw for near vision, in order to minimize training bias.
Prior to this, a stereoscopic acuity test will be performed to confirm the presence of binocular vision.
다른 이름들:
Assessment of ocular dominance for:
다른 이름들:
Conducting an orthoptic evaluation to verify that patients meet the study's inclusion criteria:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Amplitude of fusional vergence
기간: Day 0
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Values of horizontal fusional vergence measured using a horizontal Berens prism bar in divergence and convergence, for distance and near vision, in the right eye and the left eye and reported in prism diopters.
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Day 0
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Laterality ocular dominance
기간: Day 0
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Assessment of ocular dominance for:
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Day 0
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Lateralization quotient value (LQ)
기간: Day 0
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Determination of the lateralization quotient value by the mean of previous responses of the ocular dominance tests.
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Day 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of the degree of agreement among the various tests for ocular dominance
기간: Day 0
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Compilation of responses to ocular dominance tests (sensorial and motor dominant eye, target eye and preferred eye) and lateralization quotient.
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Day 0
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Agreeement between the bilateral prismatic test (new test for oculomotor dominance laterality determination and standard ocular dominance tests
기간: Day 0
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Evaluation of a new test (bilateral prismatic test for oculomotor dominance) and comparison to usually ocular dominance test.
All tests classify the ocular dominance into 3 categories : Left, Right, None.
This part tends to evaluation the efficacity and the utility of a new test for ocular dominance.
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Day 0
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Assessment of the difference in fusional vergence measurements between the right and left eyes and the laterality quotient
기간: Day 0
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Assessment of the difference in fusional vergence measurements between the right and left eyes and the laterality quotient.
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Day 0
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Correlation between inter-pupillary distance measurements and differences in fusion amplitude measurements between the right and left eyes
기간: Day 0
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Measurements of interpupillary distance and overall fusion ability, for distance vision and near vision.
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Day 0
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maxence Rateaux, PhD, Assistance Publique - Hôpitaux de Paris
- 연구 책임자: Dominique MD, PhD BREMOND-GIGNAC, Assistance Publique - Hôpitaux de Paris
간행물 및 유용한 링크
일반 간행물
- Lopes-Ferreira D, Neves H, Queiros A, Faria-Ribeiro M, Peixoto-de-Matos SC, Gonzalez-Meijome JM. Ocular dominance and visual function testing. Biomed Res Int. 2013;2013:238943. doi: 10.1155/2013/238943. Epub 2013 Nov 11.
- Rovira-Gay C, Mestre C, Argiles M, Vinuela-Navarro V, Pujol J. Feasibility of measuring fusional vergence amplitudes objectively. PLoS One. 2023 May 4;18(5):e0284552. doi: 10.1371/journal.pone.0284552. eCollection 2023.
- Rowe FJ. Fusional vergence measures and their significance in clinical assessment. Strabismus. 2010 Jun;18(2):48-57. doi: 10.3109/09273971003758412.
- Bossi M, Hamm LM, Dahlmann-Noor A, Dakin SC. A comparison of tests for quantifying sensory eye dominance. Vision Res. 2018 Dec;153:60-69. doi: 10.1016/j.visres.2018.09.006. Epub 2018 Oct 22.
- Lanca CC, Rowe FJ. Measurement of fusional vergence: a systematic review. Strabismus. 2019 Jun;27(2):88-113. doi: 10.1080/09273972.2019.1583675. Epub 2019 Mar 1.
- Fray KJ. Fusional amplitudes: exploring where fusion falters. Am Orthopt J. 2013;63:41-54. doi: 10.3368/aoj.63.1.41.
- Fray KJ. Fusional Amplitudes: Developing Testing Standards. Strabismus. 2017 Sep;25(3):145-155. doi: 10.1080/09273972.2017.1349814. Epub 2017 Jul 31.
- Ho R, Thompson B, Babu RJ, Dalton K. Sighting ocular dominance magnitude varies with test distance. Clin Exp Optom. 2018 Mar;101(2):276-280. doi: 10.1111/cxo.12627. Epub 2017 Oct 31.
- Kommerell G, Schmitt C, Kromeier M, Bach M. Ocular prevalence versus ocular dominance. Vision Res. 2003 Jun;43(12):1397-403. doi: 10.1016/s0042-6989(03)00121-4.
- Garcia-Perez MA, Peli E. Psychophysical Tests Do Not Identify Ocular Dominance Consistently. Iperception. 2019 Apr 29;10(2):2041669519841397. doi: 10.1177/2041669519841397. eCollection 2019 Mar-Apr.
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 연구와 관련된 용어
기타 연구 ID 번호
- APHP251987
- 2025-A02953-46 (기타 식별자: ID RCB number)
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. .
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