Corneal OpacityTrachomaNCT06000150
Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital
An observational study of Corneal Opacity, run by Omar Said at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corneal Opacity
- What is being tested?
- Corneal topography
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 30 Aug 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with trachomatous corneal opacity
Who may be able to join
- patients with corneal opacity accompanied by signs of trachoma
Who cannot join
- corneal opacity due other causes
- history of corneal surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Corneal Opacity
- Being tested
- Corneal topography
- Medical subject headings
- Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal topographyDiagnostic test
AS-OCT,PENTACAM
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal imaging
AS-OCT and PENTACAM in patients with trachomatous corneal opacity
Measured: we will recruit patients who meer the inclusion criteria during the study period february-August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Feb 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal OpacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Omar Said
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Said, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000150
- Sponsor's protocol ID
- M356
- Acronym
- Trachoma
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital
- ClinicalTrials.gov ID
- NCT06000150
- Acronym / sponsor ID
- Trachoma / M356
- Conditions
- Corneal Opacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Omar SaidUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with trachomatous corneal opacity
Key inclusion criteria (1 listed)
- patients with corneal opacity accompanied by signs of trachoma
Key exclusion criteria (2 listed)
- corneal opacity due other causes
- history of corneal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal topographyAS-OCT,PENTACAM | Diagnostic test | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Opacity, run by Omar Said at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal imaging (time frame: we will recruit patients who meer the inclusion criteria during the study period february-August 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.