| CTRI Number |
CTRI/2025/07/090792 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see the difference in vision of patients of diabetic with complication of vitreous hemorrhage with different-different surgery techniques. |
|
Scientific Title of Study
|
An Observational Study To Evaluate The Visual Outcome Of Internal Limiting Membrane Peeling Versus No Peeling During Vitrectomy For Diabetic Vitreous Hemorrhage |
| 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 Jyoti Nagar |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room No. C-4, ground floor, Department of Ophthalmology, Sawai Man Singh College and Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8118835855 |
| Fax |
|
| Email |
jyotinagar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Senior Professor and Head of Department |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room No. C-4, ground floor, Department of Ophthalmology, Sawai Man Singh College and Hospital, Jaipur
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 and Head of Department |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room No. C-4, ground floor, Department of Ophthalmology, Sawai Man Singh College and Hospital, Jaipur
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(302004), Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department Of Ophthalmology, SMS Medical College and Hospital, Jaipur(302004), Rajasthan, India |
| 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 Jyoti Nagar |
SMS Medical College and Hospital |
Department Of Ophthalmology, Charak Bhawan, Jaipur(302004)
Jaipur
RAJASTHAN |
08118835855
jyotinagar98@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed written consent.
Age group- 18 to 80 years.
Type 1 OR 2 Diabetes mellitus.
Vitreous hemorrhage secondary to PDR.
BCVA on snellen ranging from 20/40 to light perception with projection. |
|
| ExclusionCriteria |
| Details |
Patient having underlying retinal detachment or extensive vitreoretinal adhesion.
Optic nerve or retina disorder unrelated to diabetes mellitus (glaucoma, optic neuritis, macular degeneration, etc.)
NVG with elevated IOP (IOP greater than 30mmHg).
Medically uncontrolled systemic hypertension (systolic greater than 200 mmHg or diastolic greater than120 mmHg) despite antihypertensive therapy.
Previous history of vitrectomy.
Medically uncontrolled blood sugar despite treatment.
Diabetic nephropathy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the visual outcome of Internal Limiting Membrane peeling during vitrectomy versus no peeling in diabetic vitreous hemorrhage. |
To evaluate the visual outcome of Internal Limiting Membrane peeling versus no peeling during vitrectomy in diabetic vitreous hemorrhage at 1 week, 1 month and 3 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the central macular thickness on optical coherence tomography.
To assess the incidence of secondary epiretinal membrane. |
at 1 week, 1 month and 3 month. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/07/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an observational study being conducted at SMS Medical college and Hospital ,at department of ophthalmology to evaluate the visual outcome of internal limiting membrane peeling versus no peeling in proliferative diabetic patients undergoing pars plana vitrectomy for the treatment of diabetic vitreous hemorrhage. Patients will be recruited from SMS eye OPD. All patient undergoing pars plana vitrectomy for diabetic vitreous hemorrhage will be included in study. pre op detailed ophthalmic assessment done includes visual acuity, tonometry and fundus evaluation. Decision to peel ILM determined by surgeon base on intra op condition. Post op visual assessment, tonometry and optical coherence tonography will be done at 1 week , 1 month and 3 months, and compare between ILM peeling and non ILM peeling was done. final visual acuity will be compared in both group internal limiting membrane peeling versus no peeling . |