- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462991
COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
July 3, 2020 updated by: Omar Said, Fayoum University
The purpose of current study is to provide a comprehensive comparison of the reliability of corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Fayoum, Egypt
- Fayoum university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
keratoconus patients
Description
Inclusion Criteria:
- topography characteristic of keratoconus (skewed asymmetric bow-tie, inferior steep spot, etc.) and at least one clinical sign e.g., slit lamp findings of Munson's sign, Vogt's striae, Fleischer's ring, apical thinning, Rizutti's sign, etc.
Exclusion Criteria:
- are advanced complications of keratoconus such as corneal scars or hydrops.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
Time Frame: we will recruit patients who meer the inclusion criteria during the study period januray-August 2020
|
In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT . KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER |
we will recruit patients who meer the inclusion criteria during the study period januray-August 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
July 3, 2020
First Submitted That Met QC Criteria
July 3, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 3, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M 354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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