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CompletedNCT02812563AFRIKUpdated Nov 13, 2017

Familial Analysis of Keratoconus Risk

An observational study in Keratoconus, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
95
Ages
7 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Keratoconus

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In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 95 is below the median of 130 across 94 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

100 patients + 2-5 members of family.

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

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
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Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
95 participants (actual)
Patient registry
No

Interventions

  • Othergenetic

    Galilee exam - Corn analysis with Optiwave Refractive Analysis

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What researchers measure

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

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Study locations

1 site
  • Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin
    Bordeaux, 33000, France
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References and documents

Publications

  • Millodot M, Shneor E, Albou S, Atlani E, Gordon-Shaag A. Prevalence and associated factors of keratoconus in Jerusalem: a cross-sectional study. Ophthalmic Epidemiol. 2011 Apr;18(2):91-7. doi: 10.3109/09286586.2011.560747. PubMed 21401417 ↗
  • Weed KH, MacEwen CJ, Giles T, Low J, McGhee CN. The Dundee University Scottish Keratoconus study: demographics, corneal signs, associated diseases, and eye rubbing. Eye (Lond). 2008 Apr;22(4):534-41. doi: 10.1038/sj.eye.6702692. Epub 2007 Jan 19. PubMed 17237755 ↗
  • Assiri AA, Yousuf BI, Quantock AJ, Murphy PJ. Incidence and severity of keratoconus in Asir province, Saudi Arabia. Br J Ophthalmol. 2005 Nov;89(11):1403-6. doi: 10.1136/bjo.2005.074955. Erratum In: Br J Ophthalmol. 2006 Aug;90(8):1071. PubMed 16234439 ↗
  • Owens H, Gamble G. A profile of keratoconus in New Zealand. Cornea. 2003 Mar;22(2):122-5. doi: 10.1097/00003226-200303000-00008. PubMed 12605045 ↗
  • McMonnies CW, Boneham GC. Keratoconus, allergy, itch, eye-rubbing and hand-dominance. Clin Exp Optom. 2003 Nov;86(6):376-84. doi: 10.1111/j.1444-0938.2003.tb03082.x. PubMed 14632614 ↗
  • Falls HF, Allen AW. Dominantly inherited keratoconus. J Genet Hum. 1969 Oct;17(3):317-24. No abstract available. PubMed 5387413 ↗
  • Kemp EG, Lewis CJ. Measurement of total and specific IgE levels in the management of a family exhibiting a high incidence of keratoconus. Acta Ophthalmol (Copenh). 1984 Aug;62(4):524-9. doi: 10.1111/j.1755-3768.1984.tb03963.x. PubMed 6485750 ↗
  • Ihalainen A. Clinical and epidemiological features of keratoconus genetic and external factors in the pathogenesis of the disease. Acta Ophthalmol Suppl (1985). 1986;178:1-64. PubMed 3019073 ↗
  • Rabinowitz YS, Garbus J, McDonnell PJ. Computer-assisted corneal topography in family members of patients with keratoconus. Arch Ophthalmol. 1990 Mar;108(3):365-71. doi: 10.1001/archopht.1990.01070050063032. PubMed 2310336 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02812563
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Jun 24, 2016
Start date
Nov 25, 2014
Primary completion
Sep 19, 2017
Completion
Sep 19, 2017
Last update
Nov 13, 2017

Study contacts

David Touboul, MD
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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