NCT04462991

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 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

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 3, 2020

Last Update Submit

July 3, 2020

Conditions

The Reliability of Corneal Topographic Measurements of Keratoconus Eyes

Outcome Measures

Primary Outcomes (1)

  • Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER

    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

Interventions

corneal topographyDIAGNOSTIC_TEST

In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

keratoconus patients

You may qualify if:

  • 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.

You may not qualify if:

  • are advanced complications of keratoconus such as corneal scars or hydrops.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Interventions

Corneal Topography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
16 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 9, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(1)