| CTRI Number |
CTRI/2024/07/070929 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [laser treatment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Patients with Proliferative Diabetic Retinopathy with the help of noninvasive technique |
|
Scientific Title of Study
|
Wide-Field OCT Angiography Assessment of Regression Patterns of New Vessels Following Panretinal Photocoagulation (PRP) in Patients with Proliferative Diabetic Retinopathy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPadmaja Kumari |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, L V Prasad Marg,
GPR Building,1st floor,
Clinical Research Department,
Room NO:125,Road No:02,Banjara Hills, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102123 |
| Fax |
|
| Email |
rpk@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPadmaja Kumari |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, L V Prasad Marg,
GPR Building,1st floor,
Clinical Research Department,
Room NO:125,Road No:02,Banjara Hills, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102123 |
| Fax |
|
| Email |
rpk@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrAkshita Aggarwal |
| Designation |
Retina Fellow |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, L V Prasad Marg,
GPR Building,1st floor,
Clinical Research Department,
Room NO:125,Road No:02,Banjara Hills, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102124 |
| Fax |
|
| Email |
akshitaaggarwal1760@gmail.com |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute
L V Prasad Marg, GPR Building, 1st floor, Clinical Research Department Room No: 125
Banjara Hills, Road No:02, Hyderabad 500034, Telangana, India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, L V Prasad Marg,
GPR Building,1st floor,
Clinical Research Department,
Room NO:125,Road No:02,Banjara Hills, Hyderabad 500034, Telangana, India
|
| Type of Sponsor |
Other [Not for profit] |
|
|
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 |
| DrPadmaja Kumari |
L V Prasad Eye Institute |
L V Prasad Eye Institute, L V Prasad Marg,
GPR Building,1st floor,
Clinical Research Department,
Room NO:125,Road No:02,Banjara Hills, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA |
9000151559
rpk@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Panretinal photocoagulation |
Laser to nonperfused retina
Baseline, 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years, with diagnosis of PDR as per International clinical Diabetic Retinopathy severity scale, treatment naïve PDR needing panretinal photocoagulation with or without antivascular endothelial growth factor therapy would be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate, Patients with media haze which will prevent assessment using wide field OCTA. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best corrected visual acuity and regression pattern of PDR |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="1"
Days="1" |
|
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
|
The
present study is done with the aim of describing the efficacy of wide field
OCTA in diagnosing the regression patterns of new vessels in patients with PDR
as defined by Sivaprasad et al [11]. The
study will be a prospective analysis of the patient images obtained at 3 visits
recruited between July 2024 to September 2024. At each visit, a comprehensive
eye examination will be done along with fundus photography and Widefield OCTA. The
outcomes of the procedure will be assessed based on visual acuity, fundus
photos and wide field OCTA at baseline, 1 month and 3 months.
|