Infective KeratitisNCT04969640
Role of Anterior Segment Optical Coherence Tomography in Infectious Keratitis
An observational study of Infective Keratitis, run by Minia University at 1 site in Egypt.
Trial summary
To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Keratitis
- What is being tested?
- Optical coherence tomography
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 31 Dec 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any case with infective keratitis
Who may be able to join
- Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.
Who cannot join
- Cases with healed infectious keratitis.
- Cases presented from the start with severe corneal affection and melting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Infective Keratitis
- Being tested
- Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyOther
Anterior segment optical coherence tomography examination of corneas with infective keratitis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
criteria of lesion on optical coherence tomography
Localiztion, depth of infiltration area in microns
Measured: 1 month
width of lesion on optical coherence tomography
width of infiltration in microns
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective KeratitisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahemd Abdelghany, Minia University
- Investigators
- Ahmed Abdelghany, ASS PROF, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969640
- Sponsor's protocol ID
- 43:6/2021
- Status last verified
- Mar 2023
- First submitted
- 25 Jun 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anterior Segment Optical Coherence Tomography in Staging and Evaluation of Treatment Response in Infectious Keratitis
- ClinicalTrials.gov ID
- NCT04969640
- Acronym / sponsor ID
- 43:6/2021
- Conditions
- Infective Keratitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Jul 2021 (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.
To evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infective keratitis | – | Other: Optical coherence tomography50 cases with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any case with infective keratitis
Key inclusion criteria (1 listed)
- Any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study.
Key exclusion criteria (2 listed)
- Cases with healed infectious keratitis.
- Cases presented from the start with severe corneal affection and melting.
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 |
|---|---|---|
| Optical coherence tomographyAnterior segment optical coherence tomography examination of corneas with infective keratitis | Other | infective keratitis |
Primary outcome
criteria of lesion on optical coherence tomography
Time frame: 1 month
Localiztion, depth of infiltration area in microns
width of lesion on optical coherence tomography
Time frame: 1 month
width of infiltration in microns
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 29 Mar 2023.
- Individual participant dataSharing planned: Undecided. undecided
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.
Ahmed Abdelghany, ASS PROF principal investigator
Minia University
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 Infective Keratitis, run by Minia University 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 29 Mar 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?
criteria of lesion on optical coherence tomography (time frame: 1 month). The study lists 2 primary outcomes in all. 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 29 Mar 2023.