Corneal Endothelial Cell LossNCT05447130
Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome
A study testing phacoemulsification in people with Corneal Endothelial Cell Loss and Pseudoexfoliation Syndrome, run by Minia University at 1 site in Egypt.
Trial summary
To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Endothelial Cell Loss, Pseudoexfoliation Syndrome
- 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
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- senile cataract age more than 55 years
Who cannot join
- PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome
To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.
Read the detailed description
In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.
- Being tested
- phacoemulsification
- Keywords
- corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
- Medical subject headings
- Corneal Endothelial Cell Loss, Exfoliation Syndrome, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
phacoemulsification with corneal endothelial evaluation by specular microscopy
| Study group | Role | What they receive |
|---|---|---|
| Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome | Experimental | Not described Receives: Procedure: phacoemulsification |
| Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation | Experimental | Not described Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelial cell loss
corneal endothelial cell loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Mar 2019
- Primary completion20 Dec 2020
- Study completion31 Dec 2020
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT05447130
- Sponsor's protocol ID
- PEX2019
- Status last verified
- Sep 2022
- First submitted
- 3 Jul 2022
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome
- ClinicalTrials.gov ID
- NCT05447130
- Acronym / sponsor ID
- PEX2019
- Keywords
- corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jul 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.
To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.
Detailed description
In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome | Experimental | Procedure: phacoemulsification |
| Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation | Experimental | Procedure: phacoemulsification |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- senile cataract age more than 55 years
Key exclusion criteria (1 listed)
- PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.
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 |
|---|---|---|
| phacoemulsificationphacoemulsification with corneal endothelial evaluation by specular microscopy | Procedure or surgery | Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome, Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation |
Primary outcome
corneal endothelial cell loss
Time frame: 6 months
corneal endothelial cell loss
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 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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 Corneal Endothelial Cell Loss and Pseudoexfoliation Syndrome, 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 1 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 13 Sep 2022. 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?
corneal endothelial cell loss (time frame: 6 months). 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 13 Sep 2022.