NCT02886611

Brief Summary

The study aims at searching for a genotype-phenotype correlation in patients with a genetic pathology of the ocular surface, in order to identify genetic abnormalities associated with the most severe clinical situations.

Trial Health

77
On Track

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
6mo left

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress95%
Dec 2015Dec 2026

Study Start

First participant enrolled

December 15, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

10 years

First QC Date

August 29, 2016

Last Update Submit

December 2, 2025

Conditions

Limbus Corneae

Outcome Measures

Primary Outcomes (1)

  • Genotype-phenotype Correlation

    baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with decreased visual acuity of corneal origin will be selected and genetic analysis will be performed.

You may qualify if:

  • genetic pathology of ocular surface

You may not qualify if:

  • Agonal glaucoma
  • Low vision mostly related to retinal pathology
  • Pregnant or breast feeding patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

RECRUITING

Study Officials

  • Anna GEMAHLING, MD

    Hôpital Fondation Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

  • Eric GABISON, MD

    Hôpital Bichat (AP-HP)

    PRINCIPAL INVESTIGATOR

  • Dominique BREMOND-GIGNAC, MD

    Hopital Necker-enfants malades (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YAVCHITZ, MD, PhD

CONTACT

0033148036454ayavchitz@for.paris

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

December 15, 2015

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations

FR(1)