Familial Analysis of Keratoconus Risk (AFRIK)

November 9, 2017 updated by: University Hospital, Bordeaux

The principal objective of this study is to evaluate the frequency of KC inside family of patients with confirmed KC.

It's a familial, epidemiological, prospective, single-center study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation.

Currently, keratoconus has not known etiopathogenesis, and it is difficult to detect subclinical forms.

Several risk factors seem to be implied, environmental and genetic : the risk of keratoconus in case of familial history of keratoconus isn't well known at that time, but seems to be important to consider to promote screening and follow up of patient with a familial history of keratoconus (KC).

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 patients + 2-5 members of family.

Description

Inclusion Criteria:

Case :

  • patient carrier of keratoconus
  • more than 7 years
  • patient who didn't expressed opposition as for computerization and use of data concerning him

Family of case

  • to have a first degree family member (father, mother, brother, sister, child) carrier of keratoconus
  • more than 7 years
  • patient who didn't expressed opposition as for computerization and use of data concerning him

Exclusion Criteria:

  • ocular pathology or antecedent of modification of cornea (surgery, traumatism, ocular hypertension, keratitis) which could interfere with topographical analysis
  • wearing of rigid contact lens for 15 days before exams, or flexible lens for 5 days before exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of diagnosed keratoconus
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Assesment of familial history on KC severity
Time Frame: 1 day
1 day
Evaluation of KC severity
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: David Touboul, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2014

Primary Completion (Actual)

September 19, 2017

Study Completion (Actual)

September 19, 2017

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2013/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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