| CTRI Number |
CTRI/2021/01/030217 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the effects of PanRetinal Photocoagulation in Diabetic Retinopathy |
|
Scientific Title of Study
|
Evaluation Of The Effects Of Pan Retinal Photocoagulation In Diabetic Retinopathy Using Optical Coherence Tomography Angiography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Shaw |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 101,
Guru Nanak Eye Centre,
Maulana Azad Medical College
Bahadur Shah Zafar Marg,New Delhi-02
Bahadur Shah Zafar Marg, New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8240551491 |
| Fax |
|
| Email |
d.ektashaw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Punita Kumari Sodhi |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology
Maulana Azad Medical College,
New Delhi- 02
Bahadur Shah Zafar Marg,
New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9891373756 |
| Fax |
|
| Email |
sodhipunita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Punita Kumari Sodhi |
| Designation |
Professor, Department of Ophthalmology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology
Maulana Azad Medical College,
New Delhi- 02
Bahadur Shah Zafar Marg,
New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9891373756 |
| Fax |
|
| Email |
sodhipunita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, New Delhi- 110002 |
| 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 |
| Ekta Shaw |
Guru Nanak Eye Center |
Guru Nanak Eye Center, Maulana Azad Medical College, Bahadur Shah Zafar MargNew Delhi-110002
New Delhi
DELHI |
8240551491
d.ektashaw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H352||Other non-diabetic proliferative retinopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foveal Avascular zone |
To compare the Post PRP Foveal Avascular Zone in the patient’s eye from the pre PRP value |
| Intervention |
Pan Retinal Photocoagulation
|
All patients will be treated with Panretinal Photocoagulation,performed at two to three consecutive sessions with adherence to the guidelines of ETDRS Research Group.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects in the age range of 40-70 years, undergoing full panretinal photocoagulation , for very severe non-proliferative diabetic retinopathy and early proliferative diabetic retinopathy
Subjects having best corrected visual acuity of at least 6/60 |
|
| ExclusionCriteria |
| Details |
Subjects having other significant ocular or systemic diseases like glaucoma, media opacity, optic atrophy, retinal disease, central nervous system disease or tumours
Subjects with history of previous treatment for diabetic retinopathy including anti-VEGF and laser |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Optical Coherence Tomography Angiography parameters ( Foveal Avascular Zone) |
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in Optical Coherence Tomography Angiography parameters ( Central Macular Thickness)
2. Changes in Optical Coherence Tomography parameters (Retinal Nerve Fibre Layer) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/01/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Evaluation of the effects of Panretinal Photocoagulation in Diabetic Retinopathy ( very severe non proliferative diabetic retinopathy and early proliferative diabetic retinopathy) Using Optical Coherence Tomography Angiography 1. Changes in Optical Coherence Tomography Angiography parameters- Foveal Avascular Zone 2. Changes in Optical Coherence Tomography Angiography parameters- Central Macular Thickness 3. Changes in Optical Coherence Tomography parameter- Retinal Nerve Fibre Layer |