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NCT06000150 Clinical Trial

Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital

Corneal Opacity Clinical Trial

— Trachoma  

Official title:
Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06000150
Other study ID # M356
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date August 30, 2022

Study information
Verified date August 2023
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to assess the characteristics of trachomatous corneal opacity in patients with signs of trachoma using Anterior segment Optic coherence tomography and Pentacam

Description:

After approval of the local institutional ethics committee and local institutional review board, patient presented to Fayoum University Hospital was examined for corneal opacity with signs of trachoma after a detailed informed consent was signed by eligible patients and investigated by Anterior Segment Optic coherence Tomography and Pentacam. Descriptive statistics were presented in the form of mean and standard deviation for numerical variables while numbers and percentages are used for the categorical variables. Paired samples t-test was used to study anterior segment Optic Coherence tomography and pentacam in evaluating corneal thickness. Bland-Altman plot was used to study the agreement between the two methods IBM SPSS version 28 for Windows software was used for the analysis and Stata 16 was used for the Bland-Altman plot. A p-value of < 0.05 was considered significant.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with corneal opacity accompanied by signs of trachoma Exclusion Criteria: - corneal opacity due other causes - history of corneal surgery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Corneal topography
AS-OCT,PENTACAM

Locations
Country Name City State
Egypt Fayoum University Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Omar Said

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal imaging AS-OCT and PENTACAM in patients with trachomatous corneal opacity we will recruit patients who meer the inclusion criteria during the study period february-August 2022
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