- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04969640
Role of Anterior Segment Optical Coherence Tomography in Infectious Keratitis
March 28, 2023 updated by: Ahemd Abdelghany, Minia University
Role of Anterior Segment Optical Coherence Tomography in Staging and Evaluation of Treatment Response in Infectious Keratitis
To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
50 patients with proven infectious keratitis clinically will be included in the study.
The following will be performed for all patients in initial visit and follow up:
- Slit lamp examination and photography.
- Visual acuity assessment.
Anterior segment optical coherence tomography.
- The central corneal thickness (CCT) (extracted from pachymetry map),
- Minimal corneal thickness (MCT) (extracted from pachymetry map)
- Corneal thickness at the site of the lesion (CTL) (extracted from pachymetry map or the sum of STL+ CETL)
- Stromal thickness at the center of the lesion (STL) stromal lesion (extracted from stromal map)
- Corneal epithelial thickness over the stromal lesion (CETL) at the center of the lesion (extracted from epithelial map)
Study Type
Observational
Enrollment (Actual)
23
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
-
-
-
Minya, Egypt
- Faculty of Medicine
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any case with infective keratitis
Description
Inclusion Criteria:
- Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.
Exclusion Criteria:
- Cases with healed infectious keratitis.
- Cases presented from the start with severe corneal affection and melting.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
infective keratitis
50 cases with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.
|
Anterior segment optical coherence tomography examination of corneas with infective keratitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
criteria of lesion on optical coherence tomography
Time Frame: 1 month
|
Localiztion, depth of infiltration area in microns
|
1 month
|
|
width of lesion on optical coherence tomography
Time Frame: 1 month
|
width of infiltration in microns
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Abdelghany, ASS PROF, Minia University
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)
July 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 16, 2021
First Posted (Actual)
July 21, 2021
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43:6/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.