Cornea Epithelial MappingNCT04734158
CORNEAL EPITHELIAL MAPPING IN DIABETICS
An observational study of Cornea Epithelial Mapping, run by Minia University at 1 site in Egypt.
Trial summary
The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea Epithelial Mapping
- What is being tested?
- corneal imaging
- How many people
- 153 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2019to 31 Dec 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It's a prospective cross section study. 159 eyes of 159 patients will be involved in this study, divided into three groups: (Group A) 53 eyes of diabetic patients with diabetic macular edema, (Group B) 53 eyes of diabetic patients without macular edema and (group C) 53 eyes of age matched control.
Who may be able to join
- The patients aged between 40- 60 years old of both genders.
- The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
- The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
- The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)
Who cannot join
- Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
- Ocular surface disorders (e.g. dry eye) or any corneal pathology.
- Corneal scars or epithelial dystrophies.
- Use of any topical medications.
- Elevated IOP, pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS
The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.
Read the detailed description
The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.
- Conditions
- Cornea Epithelial Mapping
- Being tested
- corneal imaging
- Keywords
- cornea epithelium OCT diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal imagingOther
corneal imaging using AS-OCT
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Not described Receives: Other: corneal imaging | |
| Diabetics with macular edema | Not described Receives: Other: corneal imaging | |
| Diabetics without macular edema | Not described Receives: Other: corneal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal epithelial thickness
corneal thickness in diabetics using OCT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start12 Aug 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornea Epithelial MappingStudies 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
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosny Ahmed Zein, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734158
- Sponsor's protocol ID
- MiniaUN
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS
- ClinicalTrials.gov ID
- NCT04734158
- Acronym / sponsor ID
- MiniaUN
- Conditions
- Cornea Epithelial Mapping
- Keywords
- cornea epithelium OCT diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 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.
The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.
Detailed description
The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: corneal imaging |
| Diabetics with macular edema | – | Other: corneal imaging |
| Diabetics without macular edema | – | Other: corneal imaging |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It's a prospective cross section study. 159 eyes of 159 patients will be involved in this study, divided into three groups: (Group A) 53 eyes of diabetic patients with diabetic macular edema, (Group B) 53 eyes of diabetic patients without macular edema and (group C) 53 eyes of age matched control.
Key inclusion criteria (4 listed)
- The patients aged between 40- 60 years old of both genders.
- The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
- The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
- The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)
Key exclusion criteria (5 listed)
- Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
- Ocular surface disorders (e.g. dry eye) or any corneal pathology.
- Corneal scars or epithelial dystrophies.
- Use of any topical medications.
- Elevated IOP, pregnancy or lactation.
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 imagingcorneal imaging using AS-OCT | Other | Diabetics with macular edema, Diabetics without macular edema, Healthy control |
Primary outcome
corneal epithelial thickness
Time frame: 2 years
corneal thickness in diabetics using OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cornea Epithelial Mapping
Not yet recruitingObservational study
Corneal Epithelial Thickness Mapping by Anterior Segment Optical Coherence Tomography in Patients With Refractive Errors
Myopia, Hyperopia
Not yet recruitingObservational study
Evaluation of Corneal Epithelial Mapping in Diagnosis of Early Keratoconus by Anterior Segment Optical Coherence Tomography
Keratoconus
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 Cornea Epithelial Mapping, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
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 epithelial thickness (time frame: 2 years). 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 11 Apr 2024.