Endothelial Cell Density LossNCT07369388
Endothelial Changes in Diabetic and Non-diabetic Patients Undergoing Phacoemulsification
A study testing Phacoemulsification in people with Endothelial Cell Density Loss, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare specular endothelial changes in diabetic and non-diabetic patients undergoing phacoemulsification by assessing endothelial cell density, coefficient of variation, and percentage of hexagonal cells preoperatively and postoperatively. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Endothelial Cell Density Loss
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 17 Jan 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Presence of senile cataract suitable for phacoemulsification
- Clear cornea with no clinical signs of endothelial decompensation
- Ability to undergo specular microscopy examination
- For the diabetic group: confirmed diagnosis of type 2 diabetes mellitus
Who cannot join
- History of previous ocular surgery or trauma
- Corneal pathology affecting the endothelium
- Glaucoma or history of raised intraocular pressure
- Pseudoexfoliation syndrome
- Intraoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specular Endothelial Changes in Diabetic and Non-diabetic Patients Undergoing Phacoemulsification
The aim of this study is to evaluate and compare specular endothelial changes in diabetic and non-diabetic patients undergoing phacoemulsification by assessing endothelial cell density, coefficient of variation, and percentage of hexagonal cells preoperatively and postoperatively. This study also seeks to provide updated evidence on the influence of diabetes on corneal endothelial response to cataract surgery and to support evidence-based strategies for optimizing surgical outcomes
- Conditions
- Endothelial Cell Density Loss
- Being tested
- Phacoemulsification
- Keywords
- Endothelial cell, Specular microscopy, Phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Cataract surgery using phacoemulsification is the most frequently performed ophthalmic procedure worldwide and is considered a highly effective and safe method for visual rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Diabetic group | Active comparator | Not described Receives: Procedure: Phacoemulsification |
| Non-Diabetic group | Active comparator | Not described Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell density
Measured: 1 week
Cell density
Measured: 1 month
Cell density
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 May 2025
- Primary completion15 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Density LossStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369388
- Sponsor's protocol ID
- Endothelial Changes
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specular Endothelial Changes in Diabetic and Non-diabetic Patients Undergoing Phacoemulsification
- ClinicalTrials.gov ID
- NCT07369388
- Acronym / sponsor ID
- Endothelial Changes
- Conditions
- Endothelial Cell Density Loss
- Keywords
- Endothelial cell, Specular microscopy, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (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 aim of this study is to evaluate and compare specular endothelial changes in diabetic and non-diabetic patients undergoing phacoemulsification by assessing endothelial cell density, coefficient of variation, and percentage of hexagonal cells preoperatively and postoperatively. This study also seeks to provide updated evidence on the influence of diabetes on corneal endothelial response to cataract surgery and to support evidence-based strategies for optimizing surgical outcomes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic group | Active comparator | Procedure: Phacoemulsification |
| Non-Diabetic group | Active comparator | Procedure: Phacoemulsification |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40 years
- Presence of senile cataract suitable for phacoemulsification
- Clear cornea with no clinical signs of endothelial decompensation
- Ability to undergo specular microscopy examination
- For the diabetic group: confirmed diagnosis of type 2 diabetes mellitus
Key exclusion criteria (5 listed)
- History of previous ocular surgery or trauma
- Corneal pathology affecting the endothelium
- Glaucoma or history of raised intraocular pressure
- Pseudoexfoliation syndrome
- Intraoperative complications
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 |
|---|---|---|
| PhacoemulsificationCataract surgery using phacoemulsification is the most frequently performed ophthalmic procedure worldwide and is considered a highly effective and safe method for visual rehabilitation | Procedure or surgery | Diabetic group, Non-Diabetic group |
Primary outcome
Cell density
Time frame: 1 week
Cell density
Time frame: 1 month
Cell density
Time frame: 3 months
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 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Recruiting
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification in people with Endothelial Cell Density Loss, run by Al-Azhar 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 5 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: finished, as of the sponsor's last update on 27 Jan 2026. 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?
Cell density (time frame: 1 week). 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 27 Jan 2026.