Pseudoexfoliation SyndromeNCT06588816
The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.
An observational study of Pseudoexfoliation Syndrome, run by Assiut University.
Trial summary
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (represented by optic disc changes using cup to disc ratio and OCT changes in retinal nerve fiber layer and ganglion cell complex) in each eye of the same patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudoexfoliation Syndrome
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients with pseudoexfoliation syndrome
Who may be able to join
- All patients with pseudoexfoliation syndrome.
Who cannot join
- previous ocular surgery or ocular trauma affecting the pupil. Any systemic or neurologic disease affecting the pupil
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (represented by optic disc changes using cup to disc ratio and OCT changes in retinal nerve fiber layer and ganglion cell complex) in each eye of the same patient with PEX.
Read the detailed description
Pseudoexfoliation (PEX) is a widespread condition that is often considered as a generalized disorder involving ocular manifestations as well as other body systems. It is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye. The effect of pseudoexfoliation on various ocular tissues has been well studied in the past decades, especially both lens and optic disc damage. Key signs in pseudoexfoliative eyes are attributed to the effect of pseudoexfoliation material on pupillary muscles, lens and optic disc. Pseudoexfoliation appears to be a common disorder in older individuals in Upper Egypt with a prevalence of 4.14%. PXF was bilateral in 82.2% of cases. It was significantly associated with cataract, glaucoma and hearing loss. Of the PXF patients, 65% had cataract, 30.3% had glaucoma and 8.1% had hearing loss. Cardiovascular and cerebrovascular diseases such as angina, aortic aneurysm, and dementia have been linked to PXS. Subjects with PXF had a two- to three-fold increased risk for glaucoma according to the Blue Mountains Eye Study. The classic sign of PXF is the visualization of white pseudoexfoliative material on the pupil margin and on the anterior lens surface. It is believed that pupil size is another indicator for the severity of the disease. In this study we correlate the pupil size with other common ocular signs in PEX such as; lens subluxation and glaucomatous damage.
- Conditions
- Pseudoexfoliation Syndrome
- Being tested
- optical coherence tomography
- Keywords
- pupil, pseudoexfoliation, pupil dilation, pupil size, pseudoexfoliation syndrome
- Medical subject headings
- Exfoliation Syndrome, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
Optical coherence tomography (OCT) is a non-invasive imaging test . It uses light waves to take cross-section pictures of the retina .
With OCT, the ophthalmologist can see each of the retina's distinctive layers, and so we can use it to study the changes in pseudoexfoliation syndrome.
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage
in each eye of the same patient with PEX we study the correlation between the pupillary size before and after dilation with intraocular pressure, lens stability and glaucomatous damage represented by optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayera Waleed Aboelwafa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588816
- Sponsor's protocol ID
- changes in pseudoexfoliation
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tekin K, Kiziltoprak H, Sekeroglu MA, Yetkin E, Bayraktar S, Yilmazbas P. Static and dynamic pupil characteristics in pseudoexfoliation syndrome and glaucoma. Clin Exp Optom. 2020 May;103(3):332-338. doi: 10.1111/cxo.12945. Epub 2019 Jul 30.
PubMed 31364197Tuteja S, Zeppieri M, Chawla H. Pseudoexfoliation Syndrome and Glaucoma. 2023 May 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK574522/
PubMed 34662036Katsi V, Pavlidis AN, Kallistratos MS, Fitsios A, Bratsas A, Tousoulis D, Stefanadis C, Manolis AJ, Kallikazaros I. Cardiovascular repercussions of the pseudoexfoliation syndrome. N Am J Med Sci. 2013 Aug;5(8):454-9. doi: 10.4103/1947-2714.117294.
PubMed 24083219Shazly TA, Farrag AN, Kamel A, Al-Hussaini AK. Prevalence of pseudoexfoliation syndrome and pseudoexfoliation glaucoma in Upper Egypt. BMC Ophthalmol. 2011 Jun 27;11:18. doi: 10.1186/1471-2415-11-18.
PubMed 21707986Plateroti P, Plateroti AM, Abdolrahimzadeh S, Scuderi G. Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma: A Review of the Literature with Updates on Surgical Management. J Ophthalmol. 2015;2015:370371. doi: 10.1155/2015/370371. Epub 2015 Oct 29.
PubMed 26605078Sangal N, Chen TC. Cataract surgery in pseudoexfoliation syndrome. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):403-8. doi: 10.3109/08820538.2014.959189.
PubMed 25325866
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.
- ClinicalTrials.gov ID
- NCT06588816
- Acronym / sponsor ID
- changes in pseudoexfoliation
- Conditions
- Pseudoexfoliation Syndrome
- Keywords
- pupil, pseudoexfoliation, pupil dilation, pupil size, pseudoexfoliation syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (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 the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (represented by optic disc changes using cup to disc ratio and OCT changes in retinal nerve fiber layer and ganglion cell complex) in each eye of the same patient with PEX.
Detailed description
Pseudoexfoliation (PEX) is a widespread condition that is often considered as a generalized disorder involving ocular manifestations as well as other body systems. It is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye. The effect of pseudoexfoliation on various ocular tissues has been well studied in the past decades, especially both lens and optic disc damage. Key signs in pseudoexfoliative eyes are attributed to the effect of pseudoexfoliation material on pupillary muscles, lens and optic disc. Pseudoexfoliation appears to be a common disorder in older individuals in Upper Egypt with a prevalence of 4.14%. PXF was bilateral in 82.2% of cases. It was significantly associated with cataract, glaucoma and hearing loss. Of the PXF patients, 65% had cataract, 30.3% had glaucoma and 8.1% had hearing loss. Cardiovascular and cerebrovascular diseases such as angina, aortic aneurysm, and dementia have been linked to PXS. Subjects with PXF had a two- to three-fold increased risk for glaucoma according to the Blue Mountains Eye Study. The classic sign of PXF is the visualization of white pseudoexfoliative material on the pupil margin and on the anterior lens surface. It is believed that pupil size is another indicator for the severity of the disease. In this study we correlate the pupil size with other common ocular signs in PEX such as; lens subluxation and glaucomatous damage.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with pseudoexfoliation syndrome
Key inclusion criteria (1 listed)
- All patients with pseudoexfoliation syndrome.
Key exclusion criteria (1 listed)
- previous ocular surgery or ocular trauma affecting the pupil. Any systemic or neurologic disease affecting the pupil
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 |
|---|---|---|
| optical coherence tomographyOptical coherence tomography (OCT) is a non-invasive imaging test . It uses light waves to take cross-section pictures of the retina . With OCT, the ophthalmologist can see each of the retina's distinctive layers, and so we can use it to study the changes in pseudoexfoliation syndrome. | Device | – |
Primary outcome
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage
Time frame: Baseline
in each eye of the same patient with PEX we study the correlation between the pupillary size before and after dilation with intraocular pressure, lens stability and glaucomatous damage represented by optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31364197Tekin K, Kiziltoprak H, Sekeroglu MA, Yetkin E, Bayraktar S, Yilmazbas P. Static and dynamic pupil characteristics in pseudoexfoliation syndrome and glaucoma. Clin Exp Optom. 2020 May;103(3):332-338. doi: 10.1111/cxo.12945. Epub 2019 Jul 30.
- Background: PubMed 34662036Tuteja S, Zeppieri M, Chawla H. Pseudoexfoliation Syndrome and Glaucoma. 2023 May 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK574522/
- Background: PubMed 24083219Katsi V, Pavlidis AN, Kallistratos MS, Fitsios A, Bratsas A, Tousoulis D, Stefanadis C, Manolis AJ, Kallikazaros I. Cardiovascular repercussions of the pseudoexfoliation syndrome. N Am J Med Sci. 2013 Aug;5(8):454-9. doi: 10.4103/1947-2714.117294.
- Background: PubMed 21707986Shazly TA, Farrag AN, Kamel A, Al-Hussaini AK. Prevalence of pseudoexfoliation syndrome and pseudoexfoliation glaucoma in Upper Egypt. BMC Ophthalmol. 2011 Jun 27;11:18. doi: 10.1186/1471-2415-11-18.
- Background: PubMed 26605078Plateroti P, Plateroti AM, Abdolrahimzadeh S, Scuderi G. Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma: A Review of the Literature with Updates on Surgical Management. J Ophthalmol. 2015;2015:370371. doi: 10.1155/2015/370371. Epub 2015 Oct 29.
- Background: PubMed 25325866Sangal N, Chen TC. Cataract surgery in pseudoexfoliation syndrome. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):403-8. doi: 10.3109/08820538.2014.959189.
- 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.
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 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nayera Waleed Aboelwafa Mohamed, Resident (+201123118005, Nayera.16285217@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (time frame: Baseline). 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 NCT06588816, which also lists 6 linked publications.
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 19 Sep 2024.