Characteristics of Trachomatous Corneal Opacity in Fayoum... | NCT06000150

Studies
Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital

NCT06000150

Sponsor

Omar Said

Status

Completed

Last Update Posted

Aug 21, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Corneal Opacity

Interventions

Corneal topography

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

Aug 12, 2023

First Submission Date that Met QC Criteria

Aug 12, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Corneal topography	Diagnostic Test	AS-OCT,PENTACAM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with corneal opacity accompanied by signs of trachoma

Exclusion Criteria:

corneal opacity due other causes
history of corneal surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with trachomatous corneal opacity

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum University		Al Fayyum		63514	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003318	Corneal Opacity

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019781	Corneal Topography

Ancestor Terms

ID	Term
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided