Pseudoexfoliation SyndromeNCT05156138
The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes
An observational study of Pseudoexfoliation Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to compare the endothelial cell count in patients with pseudoexfoliation syndrome to the the endothelial cell count in normal patients above the age of 50. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudoexfoliation Syndrome
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2022to 24 Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients above the age of 50 at the outpatient clinic
Who may be able to join
- Pesudoexfoliation Egyptian patients and controls groups must be at least 50 years old and matched from age.
- Controls will be selected from the same outpatient clinic.
Who cannot join
- Patients with history of previous intraocular surgeries, wearing contact lens and endothelial dystrophies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit university
Asyut, 71511
Ali Alhussaini, mbbch, 01124131377, ali_alhossaini@yahoo.com
About this study
The study aims to compare the endothelial cell count in patients with pseudoexfoliation syndrome to the the endothelial cell count in normal patients above the age of 50.
Read the detailed description
Pseudoexfoliation syndrome is a systemic, age related condition, characterized by the deposition of a basement membrane like material within the anterior segment of the eye, most notably on the anterior lens capsule, the iris, the anterior chamber angle, and the anterior vitreous. Both genetic and environmental factors may play a role in its pathogenesis . This condition may present unilaterally or bilaterally and is known to be a major risk factor for secondary open angle glaucoma. Pseudoexfoliation glaucoma is seen in up to 50% of eyes with pseudoexfoliation. In contrast to primary open angel glaucoma, this disease runs a more aggressive clinical course with high intraocular pressure at onset, fast rate of progression, poor the response to medical therapy is, as well as increased need for surgical intervention.
The prevalence of pseudoexfoliation syndrome demonstrates considerable geographic, ethnic and racial variation, ranging from low rates (< 6% in patients older than 70 years) to higher rates (more than 15%) in other regions. In Egypt, the reported incidence of pseudo-exfoliation syndrome in the population older than 40 years of age is 4.14%.
Several studies have shown the influence of pseudoexfoliation syndrome on the corneal endothelium cell density (ECD). Multiple studies showed decreased ECDs of patients with pseudoexfoliation syndrome compared to control patients. However, since the pseudoexfoliation syndrome varies greatly between different populations, in terms of prevalence and progression, it is valuable to study the potential corneal endothelial cell changes in an Egyptian population.
Factors that can change corneal density include Age, race, history of intraocular surgery, use of contact lenses and endothelial dystrophies. That's why in this study, history of intraocular surgery, corneal endothelial dystrophies and contact lens use are among exclusion criteria and includes patients 50 years in age or older.A low endothelial cell count may be a risk in cataract surgery if needed.
- Conditions
- Pseudoexfoliation Syndrome
- Being tested
- no interventions as it is a case control observational study
- Keywords
- Pseudoexfoliation syndrome, Corneal endothelial count
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions as it is a case control observational studyOther
no interventions as it is a case control observational study
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with pseudoexfoliation fulfilling the inclusion criteria Receives: Other: no interventions as it is a case control observational study | |
| control group | patients without pseudoexfoliation fulfilling the inclusion criteria Receives: Other: no interventions as it is a case control observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring:
- Endothelial cell density by specular microscopy to be categorized qualitatively into one of two groups (normal/abnormal cell count):
- A group with normal cell count (2100-3200 cells/mm2) B. A group with low or abnormal cell count (less than the previous range).
- Pseudoexfoliation presence: to qualitatively categorize patients into one of two groups (pseudoexfoliation/ No pseudoexfoliation)
Measured: one year
Secondary outcomes (1)
Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start24 Jan 2022 (estimated)
- Primary completion24 Jul 2022 (estimated)
- Study completion24 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation SyndromeStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ashraf Alhussaini, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156138
- Sponsor's protocol ID
- AssiutUAA
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes
- ClinicalTrials.gov ID
- NCT05156138
- Acronym / sponsor ID
- AssiutUAA
- Conditions
- Pseudoexfoliation Syndrome
- Keywords
- Pseudoexfoliation syndrome, Corneal endothelial count
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (estimated)
- Primary completion
- 24 Jul 2022 (estimated)
- Study completion
- 24 Sep 2022 (estimated)
- First posted
- 14 Dec 2021 (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 study aims to compare the endothelial cell count in patients with pseudoexfoliation syndrome to the the endothelial cell count in normal patients above the age of 50.
Detailed description
Pseudoexfoliation syndrome is a systemic, age related condition, characterized by the deposition of a basement membrane like material within the anterior segment of the eye, most notably on the anterior lens capsule, the iris, the anterior chamber angle, and the anterior vitreous. Both genetic and environmental factors may play a role in its pathogenesis . This condition may present unilaterally or bilaterally and is known to be a major risk factor for secondary open angle glaucoma. Pseudoexfoliation glaucoma is seen in up to 50% of eyes with pseudoexfoliation. In contrast to primary open angel glaucoma, this disease runs a more aggressive clinical course with high intraocular pressure at onset, fast rate of progression, poor the response to medical therapy is, as well as increased need for surgical intervention.
The prevalence of pseudoexfoliation syndrome demonstrates considerable geographic, ethnic and racial variation, ranging from low rates (< 6% in patients older than 70 years) to higher rates (more than 15%) in other regions. In Egypt, the reported incidence of pseudo-exfoliation syndrome in the population older than 40 years of age is 4.14%.
Several studies have shown the influence of pseudoexfoliation syndrome on the corneal endothelium cell density (ECD). Multiple studies showed decreased ECDs of patients with pseudoexfoliation syndrome compared to control patients. However, since the pseudoexfoliation syndrome varies greatly between different populations, in terms of prevalence and progression, it is valuable to study the potential corneal endothelial cell changes in an Egyptian population.
Factors that can change corneal density include Age, race, history of intraocular surgery, use of contact lenses and endothelial dystrophies. That's why in this study, history of intraocular surgery, corneal endothelial dystrophies and contact lens use are among exclusion criteria and includes patients 50 years in age or older.A low endothelial cell count may be a risk in cataract surgery if needed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: no interventions as it is a case control observational studypatients with pseudoexfoliation fulfilling the inclusion criteria |
| control group | – | Other: no interventions as it is a case control observational studypatients without pseudoexfoliation fulfilling the inclusion criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients above the age of 50 at the outpatient clinic
Key inclusion criteria (2 listed)
- Pesudoexfoliation Egyptian patients and controls groups must be at least 50 years old and matched from age.
- Controls will be selected from the same outpatient clinic.
Key exclusion criteria (1 listed)
- Patients with history of previous intraocular surgeries, wearing contact lens and endothelial dystrophies.
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 |
|---|---|---|
| no interventions as it is a case control observational studyno interventions as it is a case control observational study | Other | control group, study group |
Primary outcome
to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring:
Time frame: one year
1. Endothelial cell density by specular microscopy to be categorized qualitatively into one of two groups (normal/abnormal cell count): A. A group with normal cell count (2100-3200 cells/mm2) B. A group with low or abnormal cell count (less than the previous range). 2. Pseudoexfoliation presence: to qualitatively categorize patients into one of two groups (pseudoexfoliation/ No pseudoexfoliation)
1 secondary outcome
Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome, run by Assiut 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 2 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Alhussaini, mbbch (01124131377, ali_alhossaini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring: (time frame: one year). 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 14 Dec 2021.