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CompletedNCT06000150TrachomaUpdated Aug 21, 2023

Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital

An observational study in Corneal Opacity, sponsored by Omar Said. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Omar Said · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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

Read the 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.

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Conditions studied

  • Corneal Opacity

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03

In context

Corneal Opacity

37 studies on the registry are indexed under Corneal Opacity; 5 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 14 observational studies indexed under Corneal Opacity.

Browse Corneal Opacity studies →

Lead sponsor

Omar Said is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with trachomatous corneal opacity

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with corneal opacity accompanied by signs of trachoma

Exclusion criteria

Exclusion Criteria:

  • corneal opacity due other causes
  • history of corneal surgery
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • Diagnostic testCorneal topography

    AS-OCT,PENTACAM

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What researchers measure

Primary outcomes

  1. Corneal imaging

    AS-OCT and PENTACAM in patients with trachomatous corneal opacity

    Time frame: we will recruit patients who meer the inclusion criteria during the study period february-August 2022

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Study locations

1 site
  • Fayoum University
    Fayoum, 63514, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Aug 2022, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2023
First posted
Aug 21, 2023
StartActual
Feb 1, 2022
Primary completionActual
Aug 30, 2022
CompletionActual
Aug 30, 2022
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06000150
Lead sponsor
Omar Said
Responsible party
Omar Said (Assistant Professor of Ophthalmology, Fayoum University) — Sponsor-investigator
First posted
Aug 21, 2023
Start date
Feb 1, 2022
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update
Aug 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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