| CTRI Number |
CTRI/2026/03/105329 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
understanding the prevalence of flaky eye syndrome how common it is and its key manifestations in patients presenting to Dr susheela tiwari hospital haldwani |
|
Scientific Title of Study
|
Prevalence And Ocular Manifestations Of Pseudo exfoliation Syndrome In Patients [greator than 40 years ] Presenting To Eye OPD of Dr. Susheela Tiwari Hospital Of Kumaun Region |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika joshi |
| Designation |
PG Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Room no 26 Eye opd Department Of Ophthalmology Government Medical College Haldwani
Room no 26 Eye opd department of ophthalmology government Medical College Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
8171146268 |
| Fax |
|
| Email |
joshimonika1209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GS Titiyal |
| Designation |
Principal , STH Government Medical College Haldwani |
| Affiliation |
Government Medical College Haldwani |
| Address |
Government Medical College Haldwani ( Department of Ophthalmology)
Nainital
UTTARANCHAL
263139
India |
| Phone |
9412905432 |
| Fax |
|
| Email |
gstitiyal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr GS Titiyal |
| Designation |
Principal , STH Government Medical College Haldwani |
| Affiliation |
Government Medical College Haldwani |
| Address |
Government Medical College Haldwani ( Department of Ophthalmology)
Nainital
UTTARANCHAL
263139
India |
| Phone |
9412905432 |
| Fax |
|
| Email |
gstitiyal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr susheela tiwari hospital government medical college haldwani |
|
|
Primary Sponsor
|
| Name |
Dr Monika joshi |
| Address |
Room no 26 Eye OPD Government Medical College Haldwani, Department of Ophthalmology |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GSTitiyal |
Dr Susheela Tiwari Hospital |
Room no 26 Eye OPD department of ophthalmology Dr Susheela Tiwari Hospital Government Medical College haldwani
Nainital
UTTARANCHAL |
8171146268
05946-282578
gstitiyal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are willing to participate in the study during the study period |
|
| ExclusionCriteria |
| Details |
Patients with primary open angle glaucoma and primary angle closure glaucoma
Patients with Congenital glaucoma and all other causes of secondary glaucoma
Patients with corneal opacity which can hinder the anterior segment examination |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of pseudo exfoliation syndrome defined as the proportion of patients more than 40 years with visible flaky material on pupillary margin lens capsule or trabecular meshwork via slit lamp biomicroscopy |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of associated ocular manifestations like nuclear cararact pseudoexfoliation glaucoma or lens subluxation |
baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pseudo exfoliation syndrome is an age related systemic condition with significant ocular implications often associated with glaucoma and cataract This study aims to determine the prevalence of PXF in the target population and to document its ocular manifestations including characteristic deposits on anterior segment structures intraocular pressure changes and lens related abnormalities By systematically evaluating patients attending ophthalmology clinics the research will provide epidemiological data on PXF and highlight its clinical spectrum The findings are expected to contribute to early detection better management strategies and improved visual outcomes in affected individuals |