Familial Analysis of Keratoconus Risk

NCT ID: NCT02812563

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-25

Study Completion Date

2017-09-19

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Keratoconus

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Interventions

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genetic

Galilee exam - Corn analysis with Optiwave Refractive Analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Touboul, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

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

Bordeaux, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21401417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17237755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16234439 (View on PubMed)

Owens H, Gamble G. A profile of keratoconus in New Zealand. Cornea. 2003 Mar;22(2):122-5. doi: 10.1097/00003226-200303000-00008.

Reference Type BACKGROUND
PMID: 12605045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14632614 (View on PubMed)

Falls HF, Allen AW. Dominantly inherited keratoconus. J Genet Hum. 1969 Oct;17(3):317-24. No abstract available.

Reference Type BACKGROUND
PMID: 5387413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6485750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3019073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2310336 (View on PubMed)

Other Identifiers

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CHUBX2013/03

Identifier Type: -

Identifier Source: org_study_id