Familial Analysis of Keratoconus Risk

Keratoconus Clinical Trial

— AFRIK  

Official title:

Familial Analysis of Keratoconus Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812563
• Other study ID #: CHUBX2013/03
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: November 9, 2017
• Start date: November 25, 2014
• Est. completion date: September 19, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 19, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
France	Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (9)

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. Erratum in: Br J Ophthalmol. 2006 Aug;90(8):1071. — View Citation

Falls HF, Allen AW. Dominantly inherited keratoconus. J Genet Hum. 1969 Oct;17(3):317-24. — View Citation

Ihalainen A. Clinical and epidemiological features of keratoconus genetic and external factors in the pathogenesis of the disease. Acta Ophthalmol Suppl. 1986;178:1-64. — View Citation

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. — View Citation

McMonnies CW, Boneham GC. Keratoconus, allergy, itch, eye-rubbing and hand-dominance. Clin Exp Optom. 2003 Nov;86(6):376-84. — View Citation

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. — View Citation

Owens H, Gamble G. A profile of keratoconus in New Zealand. Cornea. 2003 Mar;22(2):122-5. — View Citation

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. — View Citation

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. Epub 2007 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of diagnosed keratoconus		1 day
Secondary	Assesment of familial history on KC severity		1 day
Secondary	Evaluation of KC severity		1 day