NCT02812563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
12 months until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

July 7, 2015

Last Update Submit

November 9, 2017

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • proportion of diagnosed keratoconus

    1 day

Secondary Outcomes (2)

  • Assesment of familial history on KC severity

    1 day

  • Evaluation of KC severity

    1 day

Interventions

geneticOTHER

Galilee exam - Corn analysis with Optiwave Refractive Analysis

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 patients + 2-5 members of family.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bordeaux, 33000, France

Location

Related Publications (9)

  • 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.

    PMID: 21401417BACKGROUND

  • 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.

    PMID: 17237755BACKGROUND

  • 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.

    PMID: 16234439BACKGROUND

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

    PMID: 12605045BACKGROUND

  • 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.

    PMID: 14632614BACKGROUND

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

    PMID: 5387413BACKGROUND

  • 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.

    PMID: 6485750BACKGROUND

  • 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.

    PMID: 3019073BACKGROUND

  • 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.

    PMID: 2310336BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • David Touboul, MD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

June 24, 2016

Study Start

November 25, 2014

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)