NCT04092426

Brief Summary

Keratoconus is a degenerative disease entity characterized by conical shape ectasia of the cornea. progressive conical deformation of the cornea leads to substantial astigmatism. Patients who are at an advanced stage of ectasia are often led to corneal transplant or other treatments, which essentially aim at correcting the refractive error and not in treating the ectasia. The top of the protruding cone that corneal configuration may be close to the visual axis or below and nasal of that. The disease manifests during adolescence, followed by slow progressive course, although it is possible to stabilize anytime. In 85% of cases both eyes are affected, but the severity of the attack can present significant asymmetry.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Status
unknown

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

First Submitted

Initial submission to the registry

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 15, 2019

Last Update Submit

September 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of keratoconus in different areas in assiut

    Number of keratoconus cases detected areas in indivduals attending refractive surgery centers in Assiut

    one year

Study Arms (1)

patients with keratoconus

patients with keratoconus attending refractive surgery centers in Assiut will be subjected to the following :- 1. Full history and clinical evaluation. 2. collection of individual data ( residency , occupation , special habbit , chronic illness ) 3. Analysis of results to assess prevelance of keratoconus and its distribution geographically in Assiut

Other: opthalmologic examination

Interventions

opthalmologic examination : Refraction Best corrected visual acuity Intraocular pressure Slit lamp examination

patients with keratoconus

Eligibility Criteria

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

patients with keratoconus in people attending refractive surgery

You may qualify if:

  • persons attending refractive surgery centers in Asssiut.
  • patients found to have keratoconus are included , based on history , clinical examination and corneal topography

You may not qualify if:

  • patients not attending those refractive surgery centers.
  • patients attending these centers but not diagnosed to be keratoconus .
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jonas JB, Nangia V, Matin A, Kulkarni M, Bhojwani K. Prevalence and associations of keratoconus in rural maharashtra in central India: the central India eye and medical study. Am J Ophthalmol. 2009 Nov;148(5):760-5. doi: 10.1016/j.ajo.2009.06.024. Epub 2009 Aug 11.

    PMID: 19674732BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 17, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

September 17, 2019

Record last verified: 2019-09