- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613517
Study of the Angle Lambda and Ocular Dominance (EPOLAF)
Study of the Correlations Between the Ocular Dominance Depth, the Angle Lambda and the Fixation Disparity in Healthy Individuals
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.
Study Overview
Detailed Description
The angle lambda corresponds to the angle formed by the pupillary axis (line passing through the center of the pupil and perpendicular to the cornea) and the line of sight (broken line between the fixation point and the fovea and passing through the center of the pupil entrance). The angle kappa corresponds to the angle between the visual axis (line between the point of fixation and the fovea: area of the retina allowing precise vision) and the pupillary axis.
The angle lambda and the angle kappa are very close, which is why the lambda angle is often equated with the kappa angle, both in practice and in the literature.
The literature reports a non-null angle kappa ranged between 1.91° ± 0.14° and 5.73° ± 0.10° in the general population. Also, studies have reported a significantly greater angle on the left eye compared to the right eye. Moreover - because of the interpupillary difference - each eye perceives the same image from a different angle, resulting in a fixation disparity, defined as the angle of the residual deviation of the visual axes when the subject fixes and binocularly merges an image. In some cases, too high a value of the disparity can lead to a fixation disorder requiring orthoptic treatment.
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 and the fixation disparity in a healthy population 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75015
- Hôpital Necker-Enfants Malades
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed major subject not opposing to their participation in the study
Exclusion Criteria:
- Subject with strabismus or organic ophthalmologic pathology
- Or presenting a visual acuity lower than 10/10th
- Or with a history of eye surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy individual
Healthy individual without eye disorder.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Value of the angle lambda
Time Frame: Day 0
|
Semi-automatic digital method of measurement by eye photograph.
|
Day 0
|
|
Ocular dominance depth
Time Frame: Day 0
|
Guillon's and Hole-In-Card tests.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fixation disparity
Time Frame: Day 0
|
Rousseau test.
|
Day 0
|
|
Ocular dominance measurements quantified by the Hole-in-the-card method
Time Frame: Day 0
|
Ocular dominance.
|
Day 0
|
|
Guillon test
Time Frame: Day 0
|
Ocular dominance.
|
Day 0
|
|
Semi-automatic method of measurement by ocular photography
Time Frame: Day 0
|
Compare the values of the lambda angle obtained using the semi-automatic method of measurement by ocular photography and the method using corneal topography.
|
Day 0
|
|
Method using corneal topography
Time Frame: Day 0
|
Compare the values of the lambda angle obtained using the semi-automatic method of measurement by ocular photography and the method using corneal topography.
|
Day 0
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maxence Rateaux, PhD, Assistance Publique - Hôpitaux de Paris
- Study Director: Dominique Bremond-Gignac, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP221023
- 2022-A01045-38 (Other Identifier: IDRCB Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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