NCT07697131

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 22, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Fusional vergenceOcular dominanceOrthoptic practice

Outcome Measures

Primary Outcomes (3)

  • Amplitude of fusional vergence

    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

  • Laterality ocular dominance

    Assessment of ocular dominance for: * The dominant eye using the monocular blur test and the red-glass test * The leading eye using the Punctum Proximum of Convergence (PPC) test with the Mawas plate and bilateral prism test for oculomotor dominance * The preferred eye using the spontaneous ocular method * The target eye using the Hole-in-Card method: hole-in-card test All tests classify the ocular dominance into 3 categories : Left, Right, None.

    Day 0

  • Lateralization quotient value (LQ)

    Determination of the lateralization quotient value by the mean of previous responses of the ocular dominance tests.

    Day 0

Secondary Outcomes (4)

  • Assessment of the degree of agreement among the various tests for ocular dominance

    Day 0

  • Agreeement between the bilateral prismatic test (new test for oculomotor dominance laterality determination and standard ocular dominance tests

    Day 0

  • Assessment of the difference in fusional vergence measurements between the right and left eyes and the laterality quotient

    Day 0

  • Correlation between inter-pupillary distance measurements and differences in fusion amplitude measurements between the right and left eyes

    Day 0

Study Arms (1)

Healthy individual

Individuals with no visual or oculomotor disorders.

Other: Fusional Vergence assessmentOther: Ocular dominance evaluationOther: Complete Orthoptic

Interventions

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.

Also known as: Measurements of sensorimotor fusion
Healthy individual

Assessment of ocular dominance for: * The dominant eye using the monocular blurriness test and the red-glass test * The leading eye using the Mawas plate Punctum Proximum convergence test and the bilateral prismatic test for oculomotor dominance * The preferred eye using the spontaneous ocular method * The target eye using the Hole-in-Card method: hole-in-card test

Also known as: Assessment of ocular dominance
Healthy individual

Conducting an orthoptic evaluation to verify that patients meet the study's inclusion criteria: * assessment of visual acuity and refraction * assessment of stereoscopic vision * cover-test to screen potential abnormal phorias * measurement of interpupillary distance

Also known as: Orthoptic evaluation
Healthy individual

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any individual between the ages of 18 and 35, inclusive, with no organic ophthalmological disorders or oculomotor disorders.

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with strabismus
  • Subjects with visual acuity of less than 20/20; or anisometropia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (10)

  • 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.

    PMID: 37141181BACKGROUND
  • Rowe FJ. Fusional vergence measures and their significance in clinical assessment. Strabismus. 2010 Jun;18(2):48-57. doi: 10.3109/09273971003758412.

    PMID: 20521879BACKGROUND
  • 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.

    PMID: 30292725BACKGROUND
  • 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.

    PMID: 30821611BACKGROUND
  • Fray KJ. Fusional amplitudes: exploring where fusion falters. Am Orthopt J. 2013;63:41-54. doi: 10.3368/aoj.63.1.41.

    PMID: 24141750BACKGROUND
  • Fray KJ. Fusional Amplitudes: Developing Testing Standards. Strabismus. 2017 Sep;25(3):145-155. doi: 10.1080/09273972.2017.1349814. Epub 2017 Jul 31.

    PMID: 28759298BACKGROUND
  • 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.

    PMID: 24319677BACKGROUND
  • 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.

    PMID: 29090482BACKGROUND
  • 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.

    PMID: 12742109BACKGROUND
  • 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.

    PMID: 31069044BACKGROUND

Study Officials

  • Maxence Rateaux, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Dominique MD, PhD BREMOND-GIGNAC

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Maxence Rateaux, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations