Lens DiseasesNCT03741153
Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus
An observational study of Lens Diseases, run by Assiut University.
Trial summary
Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lens Diseases
- What is being tested?
- slit lamp
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to 14 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who will be diagnosed with pseudo-exfolian syndrome
Who may be able to join
- Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.
Who cannot join
- Patients with previous intraocular surgery.
About this study
Official title: The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population
Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.
- Conditions
- Lens Diseases
- Being tested
- slit lamp
- Medical subject headings
- Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slit lampDevice
- Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.
- Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.
- The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.
- presence of PXF material scattered on corneal endothelium.
- Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| study group | includes patients who will be diagnosed with Pseudoexfoliation syndrome Receives: Device: slit lamp | |
| control group | age matched controls who do not have Pseudoexfoliation syndrome Receives: Device: slit lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of diabetic patients with pseudo-exfoliation syndrome
slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completion14 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens DiseasesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gehad salah eldin galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741153
- Sponsor's protocol ID
- PXSDM
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 14 Nov 2018
- 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 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population
- ClinicalTrials.gov ID
- NCT03741153
- Acronym / sponsor ID
- PXSDM
- Conditions
- Lens Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 14 Mar 2021 (estimated)
- First posted
- 14 Nov 2018 (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 (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: slit lampincludes patients who will be diagnosed with Pseudoexfoliation syndrome |
| control group | – | Device: slit lampage matched controls who do not have Pseudoexfoliation syndrome |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will be diagnosed with pseudo-exfolian syndrome
Key inclusion criteria (1 listed)
- Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.
Key exclusion criteria (1 listed)
- Patients with previous intraocular 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 |
|---|---|---|
| slit lamp1. Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. 2. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. 3. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. 4. presence of PXF material scattered on corneal endothelium. 5. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma. | Device | control group, study group |
Primary outcome
the percentage of diabetic patients with pseudo-exfoliation syndrome
Time frame: 10 minutes
slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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 Lens Diseases, 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 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 Nov 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?
the percentage of diabetic patients with pseudo-exfoliation syndrome (time frame: 10 minutes). 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 Nov 2018.