Pseudoexfoliation SyndromeNCT03265457
The Endothelial Count in Pxf
An observational study of Pseudoexfoliation Syndrome, run by Assiut University.
Trial summary
Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pseudoexfoliation Syndrome
- What is being tested?
- Specular microscopy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with pseudoexfoliation syndrome
Who may be able to join
- Patients with pseudoexfoliation syndrome
Who cannot join
- Patients with previous intra ocular surgeries.
- Patients with uveitis
- Patients with fuck's endothelial dystrophy
About this study
Official title: The Corneal Endothelial Cell Count in Eyes With Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.
Read the detailed description
The corneal Endothelium is essential for the maintenance of normal corneal hydration, thickness, and transparency.
In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological changes of the corneal endothelium have been demonstrated in specular and electron microscopic studies.
Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium.
Our research question is to study Endothelial cell count in patients with pseudoexfoliation syndrome \& compare it to age matched group.
- Conditions
- Pseudoexfoliation Syndrome
- Being tested
- Specular microscopy
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular microscopyOther
Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group
| Study group | Role | What they receive |
|---|---|---|
| patient with pseudoexfoliation syndrome | The corneal Endothelial cell count will be measured by specular microscopy Receives: Other: Specular microscopy | |
| Normal people at same age | Not described Receives: Other: Specular microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.
The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy \& compared with the normal endothelial count in people at the same group
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 posted29 Aug 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Asem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265457
- Sponsor's protocol ID
- PXF
- Status last verified
- Jun 2018
- First submitted
- 26 Aug 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.
PubMed 2750833
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Corneal Endothelial Cell Count in Eyes With Pseudoexfoliation Syndrome
- ClinicalTrials.gov ID
- NCT03265457
- Acronym / sponsor ID
- PXF
- Conditions
- Pseudoexfoliation Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 29 Aug 2017 (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.
Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.
Detailed description
The corneal Endothelium is essential for the maintenance of normal corneal hydration, thickness, and transparency.
In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological changes of the corneal endothelium have been demonstrated in specular and electron microscopic studies.
Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium.
Our research question is to study Endothelial cell count in patients with pseudoexfoliation syndrome \& compare it to age matched group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with pseudoexfoliation syndrome | – | Other: Specular microscopyThe corneal Endothelial cell count will be measured by specular microscopy |
| Normal people at same age | – | Other: Specular microscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pseudoexfoliation syndrome
Key inclusion criteria (1 listed)
- Patients with pseudoexfoliation syndrome
Key exclusion criteria (3 listed)
- Patients with previous intra ocular surgeries.
- Patients with uveitis
- Patients with fuck's endothelial dystrophy
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 microscopyComparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group | Other | Normal people at same age, patient with pseudoexfoliation syndrome |
Primary outcome
Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.
Time frame: One year
The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy \& compared with the normal endothelial count in people at the same group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 2750833Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.
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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 Pseudoexfoliation Syndrome, 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 1 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 26 Jun 2018. 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?
Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265457, which also lists 1 linked publication.
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 26 Jun 2018.