Pseudoexfoliation SyndromeNCT05113121
Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome
An observational study of Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma in Both Eyes, run by Assiut University at 1 site in Egypt.
Trial summary
To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudoexfoliation Syndrome, Pseudoexfoliation Glaucoma in Both Eyes, Pseudoexfoliation of Lens; Glaucoma
- What is being tested?
- , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2021to 10 Feb 2022
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients , age : 18 years and older
Who may be able to join
- All patients with pseudoexfoliation syndrome
Who cannot join
- previous ocular surgery or ocular trauma affecting pupil. Any systemic or neurologic disease affecting pupil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Pupil Size and Ocular Signs in Pseudoexfoliation Syndrome (PEX): a Contralateral Eye Study.
To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography
Read the detailed description
For each patient. Full preoperative ophthalmological assessment will be done using slit lamp , size of the pupil in regular room light (usually around 2000 Lux) and post dilation with tropicamide 1%. baseline IOP measurement using Goldmann applanation tonometer, UCDVA (Uncorrected Distance Visual Acuity)and CDVA (Corrected Distance visual acuity), lens opacification or clarity, stability or subluxation. corneal endothelial cell count. Fundus examination using 90 D or 78D lenses, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)
- Conditions
- Pseudoexfoliation Syndrome, Pseudoexfoliation Glaucoma in Both Eyes, Pseudoexfoliation of Lens; Glaucoma
- Being tested
- , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)
- Keywords
- cataract, glaucoma
- Medical subject headings
- Exfoliation Syndrome, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)Diagnostic test
, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between pupil size and severity of Pseudoexfoliation
in each eye of the same patient we study correlation between pupil size with ntraocular pressure, lens status, corneal endothelial count and glaucomatous damage represented by (optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC)
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start25 Aug 2021
- Primary completion11 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud F. Rateb, Assiut University
- Investigators
- Mahmoud Rateb, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113121
- Sponsor's protocol ID
- PEXPUPIL
- Status last verified
- Apr 2022
- First submitted
- 28 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared upon request after completion of the research
Publications
Shazly 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 26605078Tekin 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 31364197Akman A, Yilmaz G, Oto S, Akova YA. Comparison of various pupil dilatation methods for phacoemulsification in eyes with a small pupil secondary to pseudoexfoliation. Ophthalmology. 2004 Sep;111(9):1693-8. doi: 10.1016/j.ophtha.2004.02.008.
PubMed 15350324
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pupil Size and Ocular Signs in Pseudoexfoliation Syndrome (PEX): a Contralateral Eye Study.
- ClinicalTrials.gov ID
- NCT05113121
- Acronym / sponsor ID
- PEXPUPIL
- Conditions
- Pseudoexfoliation Syndrome, Pseudoexfoliation Glaucoma in Both Eyes, Pseudoexfoliation of Lens; Glaucoma
- Keywords
- cataract, glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 9 Nov 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.
To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography
Detailed description
For each patient. Full preoperative ophthalmological assessment will be done using slit lamp , size of the pupil in regular room light (usually around 2000 Lux) and post dilation with tropicamide 1%. baseline IOP measurement using Goldmann applanation tonometer, UCDVA (Uncorrected Distance Visual Acuity)and CDVA (Corrected Distance visual acuity), lens opacification or clarity, stability or subluxation. corneal endothelial cell count. Fundus examination using 90 D or 78D lenses, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients , age : 18 years and older
Key inclusion criteria (1 listed)
- All patients with pseudoexfoliation syndrome
Key exclusion criteria (1 listed)
- previous ocular surgery or ocular trauma affecting pupil. Any systemic or neurologic disease affecting 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 |
|---|---|---|
| , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC), Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC) | Diagnostic test | – |
Primary outcome
correlation between pupil size and severity of Pseudoexfoliation
Time frame: 2-3 months
in each eye of the same patient we study correlation between pupil size with ntraocular pressure, lens status, corneal endothelial count and glaucomatous damage represented by (optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- 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 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 15350324Akman A, Yilmaz G, Oto S, Akova YA. Comparison of various pupil dilatation methods for phacoemulsification in eyes with a small pupil secondary to pseudoexfoliation. Ophthalmology. 2004 Sep;111(9):1693-8. doi: 10.1016/j.ophtha.2004.02.008.
- Individual participant dataSharing planned: Yes. IPD can be shared upon request after completion of the research
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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.
Mahmoud Rateb principal investigator
Assiut University
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 and Pseudoexfoliation Glaucoma in Both Eyes, 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 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: finished, as of the sponsor's last update on 12 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between pupil size and severity of Pseudoexfoliation (time frame: 2-3 months). 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 NCT05113121, which also lists 4 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 12 Apr 2022.