NCT03288116

Brief Summary

patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

January 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

August 30, 2017

Last Update Submit

September 15, 2017

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (3)

  • keratometric power of the corneal surface

    in diopter

    1 year

  • corneal thickness(pachymetry)

    in micrometer

    1 year

  • corneal elevations

    in micrometer

    1 year

Study Arms (3)

patient

Scheimplug imaging and contrast and sensitivity test

Diagnostic Test: Scheimplug imaging and contrast and sensitivity test

early disease

Scheimplug imaging and contrast and sensitivity test

Diagnostic Test: Scheimplug imaging and contrast and sensitivity test

normal

Scheimplug imaging and contrast and sensitivity test

Diagnostic Test: Scheimplug imaging and contrast and sensitivity test

Interventions

Scheimplug imaging and contrast and sensitivity testDIAGNOSTIC_TEST

examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.

early diseasenormalpatient

Eligibility Criteria

Age14 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

unilateral keratoconus

You may qualify if:

  • patients with clinically evident keratoconus in one eye and apparently normal in the fellow eye

You may not qualify if:

  • previous ocular surgery or truama,significant corneal scarring or associatedocular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 19, 2017

Study Start

January 2, 2014

Primary Completion

February 5, 2015

Study Completion

February 5, 2015

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share