Corneal Endothelial Cell Changes in Diabetic PatientsNCT05838898
Specular Microscopy in Patients With Proliferative Diabetic Retinopathy
An observational study of Corneal Endothelial Cell Changes in Diabetic Patients, run by Assiut University.
Trial summary
.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group. 2. The effect of the age, and duration of Diabetes on the corneal endothelium . Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Corneal Endothelial Cell Changes in Diabetic Patients
- What is being tested?
- Specular microscopy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 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
- Adult, Older adult
Study population: Image capture will be done by the same individual for all subjects. The following data will be collected and analyzed: corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness.
Who may be able to join
- patients with Type I or II Diabetes Mellitus
- .Diagnosed with proliferative diabetic retinopathy . .Intraocular pressure less than 21mmHg.
- Healthy controls:
- .Healthy individuals aged 40 to 70 years of both sexes. .Intraocular pressure less than 21 mmHg.
Who cannot join
- Diabetic group:
- Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
- Previous ocular trauma or surgery.
- Healthy control:
- Any systemic diseases that may affect corneal endothelium function.
- Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
- Previous ocular trauma , surgery ,laser or intraocular injection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes of Corneal Endothelial Cells in Patients With PDR Using Specular Microscopy
.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group.
- The effect of the age, and duration of Diabetes on the corneal endothelium .
Read the detailed description
Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels. In Egypt, diabetes is a growing public health problem.
Diabetes causes several ocular complications including diabetic retinopathy, cataract, glaucoma and ocular surface diseases.
Retinal damage caused by microangiopathy results in diabetic retinopathy which is one of the most important causes of blindness and affects approximately 40% of all diabetic patients.
Diabetic retinopathy is classified to non-proliferative diabetic retinopathy (NPDR) (mild, moderate, severe) and proliferative diabetic retinopathy (PDR) according to the severity of retinopathy.
Even though diabetic retinopathy is the most common sequel and most widely studied association of DM, other structures of the eye are not immune and get affected in various stages of the disease.
Chronic hyperglycemia can affect the corneal layers shape and functions. The resultant morphological and functional alterations increase the susceptibility of the cornea to recurrent corneal erosions, superficial keratitis, punctate epithelial keratopathy, impaired corneal sensitivity, and slowed healing capacity following trauma or surgical insult.
Considering the pivotal role of corneal endothelium in maintaining corneal clarity, several studies have investigated the possible alterations that take place in corneal endothelium in patients with DM . These studies found that DM can cause structural changes in corneal endothelial cells . Damaged corneal endothelium results in corneal oedema and increased central corneal thickness (CCT) . This increase has been documented in patients with DM as compared with healthy controls in a number of studies .
The aim of this study is to investigate the corneal endothelial cell profile and central corneal thickness in patients with proliferative diabetic retinopathy using non-contact specular microscopy.
- Being tested
- Specular microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular microscopyDevice
Non-contact Specular microscopy is a non-invasive method that allows for in vivo study of corneal endothelium.
What is being measured
The primary outcome is the main question the study is designed to answer.
To predict the effect of Diabetes on the cornea of diabetic patients
To evaluate corneal endothelial changes in patients with Proliferative diabetic retinopathy compared to normal group of the same age and gender using Specular microscopy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial Cell Changes in Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marline Reda Fahim Anis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838898
- Sponsor's protocol ID
- Specular microscopy
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2022
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortazavi SA, Akhlaghi M, Dehghani A, Pourazizi M, Malekahmadi M, Fazel M, Tavakoli M, Noorshargh P. Diabetic retinopathy and corneal endothelial parameters: an analytical cross-sectional study. BMC Ophthalmol. 2022 Nov 9;22(1):427. doi: 10.1186/s12886-022-02667-6.
PubMed 36348282Jha A, Verma A, Alagorie AR. Association of severity of diabetic retinopathy with corneal endothelial and thickness changes in patients with diabetes mellitus. Eye (Lond). 2022 Jun;36(6):1202-1208. doi: 10.1038/s41433-021-01606-x. Epub 2021 Jun 11.
PubMed 34117392
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Corneal Endothelial Cells in Patients With PDR Using Specular Microscopy
- ClinicalTrials.gov ID
- NCT05838898
- Acronym / sponsor ID
- Specular microscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 May 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.
.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group.
- The effect of the age, and duration of Diabetes on the corneal endothelium .
Detailed description
Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels. In Egypt, diabetes is a growing public health problem.
Diabetes causes several ocular complications including diabetic retinopathy, cataract, glaucoma and ocular surface diseases.
Retinal damage caused by microangiopathy results in diabetic retinopathy which is one of the most important causes of blindness and affects approximately 40% of all diabetic patients.
Diabetic retinopathy is classified to non-proliferative diabetic retinopathy (NPDR) (mild, moderate, severe) and proliferative diabetic retinopathy (PDR) according to the severity of retinopathy.
Even though diabetic retinopathy is the most common sequel and most widely studied association of DM, other structures of the eye are not immune and get affected in various stages of the disease.
Chronic hyperglycemia can affect the corneal layers shape and functions. The resultant morphological and functional alterations increase the susceptibility of the cornea to recurrent corneal erosions, superficial keratitis, punctate epithelial keratopathy, impaired corneal sensitivity, and slowed healing capacity following trauma or surgical insult.
Considering the pivotal role of corneal endothelium in maintaining corneal clarity, several studies have investigated the possible alterations that take place in corneal endothelium in patients with DM . These studies found that DM can cause structural changes in corneal endothelial cells . Damaged corneal endothelium results in corneal oedema and increased central corneal thickness (CCT) . This increase has been documented in patients with DM as compared with healthy controls in a number of studies .
The aim of this study is to investigate the corneal endothelial cell profile and central corneal thickness in patients with proliferative diabetic retinopathy using non-contact specular microscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Image capture will be done by the same individual for all subjects. The following data will be collected and analyzed: corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness.
Key inclusion criteria (4 listed)
- patients with Type I or II Diabetes Mellitus
- .Diagnosed with proliferative diabetic retinopathy . .Intraocular pressure less than 21mmHg.
- .Healthy individuals aged 40 to 70 years of both sexes. .Intraocular pressure less than 21 mmHg.
Key exclusion criteria (7 listed)
- Diabetic group:
- Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
- Previous ocular trauma or surgery.
- Any systemic diseases that may affect corneal endothelium function.
- Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
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 |
|---|---|---|
| Specular microscopyNon-contact Specular microscopy is a non-invasive method that allows for in vivo study of corneal endothelium. | Device | – |
Primary outcome
To predict the effect of Diabetes on the cornea of diabetic patients
Time frame: Baseline
To evaluate corneal endothelial changes in patients with Proliferative diabetic retinopathy compared to normal group of the same age and gender using Specular microscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 36348282Mortazavi SA, Akhlaghi M, Dehghani A, Pourazizi M, Malekahmadi M, Fazel M, Tavakoli M, Noorshargh P. Diabetic retinopathy and corneal endothelial parameters: an analytical cross-sectional study. BMC Ophthalmol. 2022 Nov 9;22(1):427. doi: 10.1186/s12886-022-02667-6.
- Background: PubMed 34117392Jha A, Verma A, Alagorie AR. Association of severity of diabetic retinopathy with corneal endothelial and thickness changes in patients with diabetes mellitus. Eye (Lond). 2022 Jun;36(6):1202-1208. doi: 10.1038/s41433-021-01606-x. Epub 2021 Jun 11.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelial Cell Changes in Diabetic Patients, run by Assiut University.
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 7 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Marline reda, Master (01275986804, Mrmrreda559@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To predict the effect of Diabetes on the cornea of diabetic patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838898, which also lists 2 linked publications.
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 3 May 2023.