NCT04886219

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 alpha and the angle kappa in a healthy individual without ophthalmologic disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

May 10, 2021

Last Update Submit

September 15, 2025

Conditions

Keywords

Angle KappaAngle AlphaPupillary axisVisual axisOptical axis

Outcome Measures

Primary Outcomes (2)

  • Value of the angle Kappa

    Semi-automatic digital method of measurement by eye photography

    Day 0

  • Value of the angle Alpha

    Semi-automatic digital method of measurement by eye photography

    Day 0

Secondary Outcomes (3)

  • Variation of the Kappa angle depending on the pupillary diameter

    Day 0

  • Correlation between the value of the angle Alpha and the Optic disc / fovea distance

    Day 0

  • Correlation between the angle Kappa and the axial length

    Day 0

Study Arms (1)

Healthy individual

Healthy individual

Other: Eye examination

Interventions

* Multimodal fundus imaging (color fundus photography, optical coherence tomography (OCT)) * orthoptic assessment (Visual acuity, Refraction, Cover test, Stereopsis evaluation * ocular biometry * corneal topography * monocular photographs in photopic and scotopic 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (2)

  • Rateaux M, Vienne-Jumeau A, Bremond-Gignac D, Robert MP. Fluctuations in angle lambda with the pupil diameter and correlations with biometric values in a healthy population. Ophthalmic Physiol Opt. 2025 Nov;45(7):1837-1844. doi: 10.1111/opo.70006. Epub 2025 Aug 14.

    PMID: 40810703BACKGROUND
  • Rateaux M, Bremond-Gignac D, Robert MP. From monocular photograph to angle lambda: A new clinical approach for quantitative assessment. J Binocul Vis Ocul Motil. 2022 Jul-Sep;72(3):169-175. Epub 2022 Jun 22.

    PMID: 35731900BACKGROUND

Study Officials

  • Maxence Rateaux

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Dominique Brémond-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

May 10, 2021

First Posted

May 14, 2021

Study Start

May 19, 2021

Primary Completion

October 4, 2021

Study Completion

October 4, 2021

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations