Corneal Endothelial Cell LossNCT05522842
Corneal Endothelium in Diabetics Undergoing Phacoemulsification
An observational study of Corneal Endothelial Cell Loss, run by Assiut University.
Trial summary
evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Corneal Endothelial Cell Loss
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Mar 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: evaluate the changes in corneal endothelium between 50 patients diabetic and non diabetic undergoing phacoemulsification
Who may be able to join
- Age from 40 to 70
- Any degree of cataract
- No previous ocular surgery
Who cannot join
- Any corneal pathology, infection, or active inflammation
- pseudoexofoliation
- History of ocular trauma or surgery
About this study
Official title: Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy
evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.
Read the detailed description
Diabetes mellitus (DM) is a major health hazard reaching epidemic proportions. Worldwide more than 285 million people are affected by DM; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. DM affects every part of the body and the eye is not an exception.
Diabetes mellitus has been found to be detrimental to corneal endothelium . Patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. Also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics.
Several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration.
Patients with DM tend to develop cataract more frequently and earlier than non diabetics.
Corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. Any compromise in these factors leads to direct effect on corneal endothelium .
Cataract has been documented to be the most significant cause of bilateral blindness .
Cataract extraction with phacoemulsification is one of the most common surgical procedure performed nowadays, with an estimated 19 million operation performed annually worldwide. The WHO states that this number will increase to 32 million by 2025, however corneal endothelium is known to undergo damage during phacoemulsification in many different ways, it may be injured mechanically as result of instrumentation causing postoperative complication such as corneal edema.
Specular microscopy is used for non invasive viewing and recording of the image of corneal endothelial cell layer. Several studies have used specular microscopy for quantitative assessment of the corneal damage associated with phacoemulsification by measuring the degree of decrease in the corneal cell density.
- Conditions
- Corneal Endothelial Cell Loss
- Medical subject headings
- Corneal Endothelial Cell Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelium cell count
normal range of 1500 to 3500 cells/mm2 (age, 40-90)
Measured: baseline
corneal endothelial cell size
their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick
Measured: baseline
corneal endothelial cell shape
a single layer of cells organized in a characteristic honeycomb pattern
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Rashad Helmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522842
- Sponsor's protocol ID
- corneal endothelium
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy
- ClinicalTrials.gov ID
- NCT05522842
- Acronym / sponsor ID
- corneal endothelium
- Conditions
- Corneal Endothelial Cell Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 31 Aug 2022 (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.
evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.
Detailed description
Diabetes mellitus (DM) is a major health hazard reaching epidemic proportions. Worldwide more than 285 million people are affected by DM; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. DM affects every part of the body and the eye is not an exception.
Diabetes mellitus has been found to be detrimental to corneal endothelium . Patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. Also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics.
Several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration.
Patients with DM tend to develop cataract more frequently and earlier than non diabetics.
Corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. Any compromise in these factors leads to direct effect on corneal endothelium .
Cataract has been documented to be the most significant cause of bilateral blindness .
Cataract extraction with phacoemulsification is one of the most common surgical procedure performed nowadays, with an estimated 19 million operation performed annually worldwide. The WHO states that this number will increase to 32 million by 2025, however corneal endothelium is known to undergo damage during phacoemulsification in many different ways, it may be injured mechanically as result of instrumentation causing postoperative complication such as corneal edema.
Specular microscopy is used for non invasive viewing and recording of the image of corneal endothelial cell layer. Several studies have used specular microscopy for quantitative assessment of the corneal damage associated with phacoemulsification by measuring the degree of decrease in the corneal cell density.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- evaluate the changes in corneal endothelium between 50 patients diabetic and non diabetic undergoing phacoemulsification
Key inclusion criteria (3 listed)
- Age from 40 to 70
- Any degree of cataract
- No previous ocular surgery
Key exclusion criteria (3 listed)
- Any corneal pathology, infection, or active inflammation
- pseudoexofoliation
- History of ocular trauma or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
corneal endothelium cell count
Time frame: baseline
normal range of 1500 to 3500 cells/mm2 (age, 40-90)
corneal endothelial cell size
Time frame: baseline
their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick
corneal endothelial cell shape
Time frame: baseline
a single layer of cells organized in a characteristic honeycomb pattern
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelial Cell Loss, 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 3 inclusion and 3 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 21 Feb 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?
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 endothelium cell count (time frame: baseline). The study lists 3 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 21 Feb 2023.