Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital

• Sponsor: Omar Said (Other)
• Overall Status: Completed
• CT.gov ID: NCT06000150
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Corneal Opacity	Diagnostic Test: Corneal topography

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital
• Actual Study Start Date: Feb 1, 2022
• Actual Primary Completion Date: Aug 30, 2022
• Actual Study Completion Date: Aug 30, 2022

Outcome Measures

Primary Outcome Measures

1. Corneal imaging [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients with corneal opacity accompanied by signs of trachoma

Exclusion Criteria:

• corneal opacity due other causes

• history of corneal surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fayoum University	Fayoum		Egypt	63514

Sponsors and Collaborators

• Omar Said

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Said, Assistant Professor of Ophthalmology, Fayoum University
• ClinicalTrials.gov Identifier: NCT06000150
• Other Study ID Numbers: M356
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Corneal Opacity

Study Results

No Results Posted as of Aug 21, 2023