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Completed

NCT Number: NCT02812563

Familial Analysis of Keratoconus Risk

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.

Completed

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin

Bordeaux, 33000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genetic

Other

Galilee exam - Corn analysis with Optiwave Refractive Analysis

Primary outcomes

  1. proportion of diagnosed keratoconus

    Time frame: 1 day

Secondary outcomes

  1. Assesment of familial history on KC severity

    Time frame: 1 day

  2. Evaluation of KC severity

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: AFRIK

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2016
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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