Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital (Trachoma)

August 12, 2023 updated by: Omar Said
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

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

  • Egypt
      • Fayoum, Egypt, 63514
        • Fayoum university

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with trachomatous corneal opacity

Description

Inclusion Criteria:

  • patients with corneal opacity accompanied by signs of trachoma

Exclusion Criteria:

  • corneal opacity due other causes
  • history of corneal surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal imaging
Time Frame: we will recruit patients who meer the inclusion criteria during the study period february-August 2022
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omar Said

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)

February 1, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

August 12, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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