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Familial Analysis of Keratoconus Risk (AFRIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812563
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

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.


Condition or disease Intervention/treatment
Keratoconus Other: genetic

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).

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Familial Analysis of Keratoconus Risk
Actual Study Start Date : November 25, 2014
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : September 19, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: genetic
    Galilee exam - Corn analysis with Optiwave Refractive Analysis


Primary Outcome Measures :
  1. proportion of diagnosed keratoconus [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Assesment of familial history on KC severity [ Time Frame: 1 day ]
  2. Evaluation of KC severity [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 patients + 2-5 members of family.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812563


Locations
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France
Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: David Touboul, MD University Hospital Bordeaux, France
Publications:
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02812563    
Other Study ID Numbers: CHUBX2013/03
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases