| CTRI Number |
CTRI/2025/02/080321 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see changes in retinal nerve fiber layer thickness in patients with or without Weiss ring at SMS Hospital |
|
Scientific Title of Study
|
A cross-sectional study of mean and sectoral peripapillary retinal nerve fiber layer thickness in patients of posterior vitreous detachment with or without weiss ring at SMS Hospital |
| 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 Pooja Hathiwal |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Sawai Man Singh Medical College and Hospital, Jaipur Department of Ophthalmology
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290408903 |
| Fax |
|
| Email |
drpoojahathiwal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Sawai Man Singh Medical College and Hospital, Jaipur Department of Ophthalmology
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Sawai Man Singh Medical College and Hospital, Jaipur Department of Ophthalmology
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology SMS Medical College and Hospital, Jaipur, Rajasthan, India Pin Code- 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital Jaipur |
| Address |
SMS Medical College and Hospital, JLN Marg, Adarsh Nagar Jaipur, Rajasthan, India Pin Code-302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Pooja Hathiwal |
SMS Medical College and Hospital, Jaipur |
Department of Ophthalmology Charak Bhawan Retina Clinic, Jaipur
Jaipur
RAJASTHAN |
8290408903
drpoojahathiwal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Hospital, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with given written and informed consent.
Patients with posterior vitreous detachment in which Weiss ring is seen.
Best corrected visual acuity.
Intra ocular pressure.
|
|
| ExclusionCriteria |
| Details |
A history of Glaucoma.
Optic Nerve disorder.
Intraocular pressure more than 21 mmhg.
Axial length more than 26mm.
Any other optic nerve or retinal dysfunction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare mean and sectoral peripapillary retinal nerve fiber layer thickness in patients of posterior vitreous detachment with or without Weiss ring |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare patients Best Corrected Visual Acuity |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After obtaining Institutional Ethics Committee Approval and written informed consent, 88 patients fulfilling the inclusion criteria will be included in this study. There are 2 groups in this study . One is Case group [with weiss ring] and the other one is Control group [without weiss ring] with sample size of 44 patients in each group. The objective of this study is to compare the peripapillary retinal nerve fiber layer thickness in patients of posterior vitreous detachment with or without weiss ring by using SD-OCT at the time of Enrollment at SMS Hospital.
|