NCT05613517

Brief Summary

Anatomical ophthalmological connections and their dynamics are still debated in the scientific community. However, their considering is essential in many surgeries (strabismus, cataract, refractive...) or in clinical practice. The correlation between these biometric values would make it possible to refine the knowledge related to these landmarks and thus offer better ophthalmological management by integrating these variables into the clinical examination. The aim of the study is to analyze the correlation between the angle lambda and the ocular dominance depth in healthy individuals without ophthalmologic disorder. Then, seconds goals were defined as the study of the relation between the value of the angle lambda and the fixation disparity quantified with the Rousseau test. Relation between ocular dominance measured with the Guillon's test and the Hole-in-car test will also studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

November 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

November 4, 2022

Last Update Submit

September 5, 2025

Conditions

Keywords

Angle lambdaOcular dominanceFixation disparityPupillary axisLine of sight

Outcome Measures

Primary Outcomes (2)

  • Value of the angle lambda

    Semi-automatic digital method of measurement by eye photograph.

    Day 0

  • Ocular dominance depth

    Guillon's and Hole-In-Card tests.

    Day 0

Secondary Outcomes (5)

  • Fixation disparity

    Day 0

  • Ocular dominance measurements quantified by the Hole-in-the-card method

    Day 0

  • Guillon test

    Day 0

  • Semi-automatic method of measurement by ocular photography

    Day 0

  • Method using corneal topography

    Day 0

Study Arms (1)

Healthy individual

Healthy individual without eye disorder.

Other: Eye examination

Interventions

* orthoptic assessment (visual acuity, refraction, stereopsis test, Cover-test, evaluation of the disparity of fixation and ocular dominance, measurement of the inter-pupillary distance * ocular biometry * corneal topography * monocular photographs in photopic condition

Healthy individual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals without visual disorders

You may qualify if:

  • \- Informed major subject not opposing to their participation in the study

You may not qualify if:

  • Subject with strabismus or organic ophthalmologic pathology
  • Or presenting a visual acuity lower than 10/10th
  • Or with a history of eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Study Officials

  • Maxence Rateaux, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Dominique Bremond-Gignac, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 14, 2022

Study Start

November 25, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations