- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Maxence Rateaux, PhD
- Numéro de téléphone: +33 01 44 49 53 62
- E-mail: maxence.rateaux@aphp.fr
Sauvegarde des contacts de l'étude
- Nom: Hélène Morel
- Numéro de téléphone: +33 01 44 38 16 53
- E-mail: helene.morel@aphp.fr
Lieux d'étude
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Paris, France, 75015
- Recrutement
- Hôpital Necker-Enfants Malades
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Contact:
- Maxence Rateaux, PhD
- Numéro de téléphone: +33 01 44 49 53 62
- E-mail: maxence.rateaux@aphp.fr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Healthy individual
Individuals with no visual or oculomotor disorders.
|
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.
Autres noms:
Assessment of ocular dominance for:
Autres noms:
Conducting an orthoptic evaluation to verify that patients meet the study's inclusion criteria:
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Amplitude of fusional vergence
Délai: Day 0
|
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.
|
Day 0
|
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Laterality ocular dominance
Délai: 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)
Délai: Day 0
|
Determination of the lateralization quotient value by the mean of previous responses of the ocular dominance tests.
|
Day 0
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessment of the degree of agreement among the various tests for ocular dominance
Délai: Day 0
|
Compilation of responses to ocular dominance tests (sensorial and motor dominant eye, target eye and preferred eye) and lateralization quotient.
|
Day 0
|
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Agreeement between the bilateral prismatic test (new test for oculomotor dominance laterality determination and standard ocular dominance tests
Délai: Day 0
|
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
Délai: 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
Délai: Day 0
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Measurements of interpupillary distance and overall fusion ability, for distance vision and near vision.
|
Day 0
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Maxence Rateaux, PhD, Assistance Publique - Hôpitaux de Paris
- Directeur d'études: Dominique MD, PhD BREMOND-GIGNAC, Assistance Publique - Hôpitaux de Paris
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- APHP251987
- 2025-A02953-46 (Autre identifiant: ID RCB number)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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