Endothelial Cell Loss, CornealPEXNCT05194891
Endothelial Changes in Pseudoexfoliation Syndrome
An observational study of Endothelial Cell Loss, Corneal, run by Assiut University.
Trial summary
this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Endothelial Cell Loss, Corneal
- What is being tested?
- Specular Microscopy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to Mar 2023
- 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 50 to 75 years
- All sexes
- Adult, Older adult
Study population: This prospective, non-randomized comparative ,interventional study was performed on 100 eyes of 100 patients who were divided equally into two groups (pseudoexfoliative and control). Patient who aged above50 years and with nuclear cataract grade II,III, clear cornea and endothelial cell density more than 1000\mm2 were included in this study. Also, patients with normal anterior chamber depth, dilatable pupil and with no active ocular disease or inflammation were included. Pseudoexfoliative patients who had glaucoma were excluded from the study.
Who may be able to join
- Patient age is above50 years.
- Patient with nuclear cataract grade II, III.
- Clear cornea with no evidence of endothelial disease.
- Endothelial cell density more than 1000\mm2.
- Normal anterior chamber depth and dilatable pupil.
- No active ocular disease or inflammation.
- Pseudoexfoliative patients.
Who cannot join
- History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
- Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
- Pseudoexfoliative glaucoma.
- Patients age below 50 years.
- Endothelial cell count less than 1000\mm2.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Specular Microscopic Changes of Corneal Endothelial Cells After Phacoemulsification in Patients With Pseudo Exfoliation
this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.
Read the detailed description
Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized by the deposition of greyish white flaky exfoliative material in ocular and extraocular tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with prevalence range from 0.5% to > 30%, Although it occurs in virtually every area of the world, a considerable racial variation exists in its incidence. It is relatively rare among African Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern Europe. There is also a high prevalence in Arabic populations. It is also well known that patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred type of cataract surgery owing to fewer complications than other types. However, it still has significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance loss of corneal endothelial cells, thickness and density that may result in corneal decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and weak zonular support may enhance Phacoemulsification complications. Non-contact Specular microscope is a non-invasive method for morphological analysis of corneal density of endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism). Therefore, this technology plays an important role in preoperative evaluation, surgical design and postoperative care.
- Conditions
- Endothelial Cell Loss, Corneal
- Being tested
- Specular Microscopy
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular MicroscopyDiagnostic test
Phacoemulsification
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of corneal endothelial changes in pseudoexfoliation syndrome
Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Loss, CornealStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Ahmed, Assiut University
- Investigators
- Shymaa Sabet, Doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194891
- Sponsor's protocol ID
- Endothelial Changes in PEX
- Acronym
- PEX
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 31 Jan 2022
- 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specular Microscopic Changes of Corneal Endothelial Cells After Phacoemulsification in Patients With Pseudo Exfoliation
- ClinicalTrials.gov ID
- NCT05194891
- Acronym / sponsor ID
- PEX / Endothelial Changes in PEX
- Conditions
- Endothelial Cell Loss, Corneal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 18 Jan 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.
this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.
Detailed description
Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized by the deposition of greyish white flaky exfoliative material in ocular and extraocular tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with prevalence range from 0.5% to > 30%, Although it occurs in virtually every area of the world, a considerable racial variation exists in its incidence. It is relatively rare among African Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern Europe. There is also a high prevalence in Arabic populations. It is also well known that patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred type of cataract surgery owing to fewer complications than other types. However, it still has significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance loss of corneal endothelial cells, thickness and density that may result in corneal decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and weak zonular support may enhance Phacoemulsification complications. Non-contact Specular microscope is a non-invasive method for morphological analysis of corneal density of endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism). Therefore, this technology plays an important role in preoperative evaluation, surgical design and postoperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This prospective, non-randomized comparative ,interventional study was performed on 100 eyes of 100 patients who were divided equally into two groups (pseudoexfoliative and control). Patient who aged above50 years and with nuclear cataract grade II,III, clear cornea and endothelial cell density more than 1000\mm2 were included in this study. Also, patients with normal anterior chamber depth, dilatable pupil and with no active ocular disease or inflammation were included. Pseudoexfoliative patients who had glaucoma were excluded from the study.
Key inclusion criteria (7 listed)
- Patient age is above50 years.
- Patient with nuclear cataract grade II, III.
- Clear cornea with no evidence of endothelial disease.
- Endothelial cell density more than 1000\mm2.
- Normal anterior chamber depth and dilatable pupil.
Key exclusion criteria (5 listed)
- History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
- Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
- Pseudoexfoliative glaucoma.
- Patients age below 50 years.
- Endothelial cell count less than 1000\mm2.
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 MicroscopyPhacoemulsification | Diagnostic test | – |
Primary outcome
Study of corneal endothelial changes in pseudoexfoliation syndrome
Time frame: Baseline
Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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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.
Shymaa Sabet, Doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Cell Loss, Corneal, 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 7 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 31 Jan 2022. 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 Shymaa Ahmed, Doctor (+20 106 319 4646, shymaa.sabet@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of corneal endothelial changes in pseudoexfoliation syndrome (time frame: Baseline). 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 31 Jan 2022.