| CTRI Number |
CTRI/2023/08/056275 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LASER] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY EFFECTIVENESS OF MICROPULSE LASER IN DIABETIC MACULAR EDEMA |
|
Scientific Title of Study
|
Evaluating The Efficacy of Subthreshold Micropulse focal Laser in Non Centre involving Clinically
significant Diabetic Macular Edema |
| 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 Rohan Chawla |
| Designation |
Additional Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
S-3, First Floor, Dr. Rajendra Prasad Centre for Ophthalmic
Sciences, All India Institute of Medical sciences, Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
S-3, First Floor, Dr. Rajendra Prasad Centre for Ophthalmic
Sciences, All India Institute of Medical sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Sharma |
| Designation |
Junior Resident |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical sciences |
| Address |
S-3, First Floor, Dr. Rajendra Prasad Centre for Ophthalmic
Sciences, All India Institute of Medical sciences, Ansari Nagar
New Delhi
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9805809201 |
| Fax |
|
| Email |
drswatiigmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
Ansari Nagar, New Delhi |
| 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 Rohan Chawla |
Dr Rajendra Prasad Centre for Ophthalmic ScienceS |
Room no 153, Retina
Lab, Department of
Ophthalmology
South
DELHI |
9891052939
dr.rohanrpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS C OMMITTEE,AIIMS,NE W DELHI Approve |
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 |
Conventional laser (532/577nm) |
Conventional laser
(532/577nm)to be done on Ten
eyes of Non centre involving
Clinically significant Diabetic
macular Edema. Frequency and
Duration: single point
intervention. . Change in macular volume and macular
thickness to be measured on
follow ups at 1,3 and 6 months
as compared to the values
before intervention |
| Intervention |
Subthreshold Micropulse focal
yellow laser(577) |
Subthreshold Micropulse focal
yellow laser (577nm)to be done
on Ten eyes of Non centre
involving Clinically significant
Diabetic macular Edema .
Frequency and Duration: single
point intervention. Change in
macular volume and macular
thickness to be measured on
follow ups at 1,3 and 6 months
as compared to the values
before intervention |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with non centre involving Clinically significant Diabetic
macular Edema
2.Central Macular Thickness on OCT<350microns
3.Patient willing to give Informed Consent
4.Patient willing to come for follow ups |
|
| ExclusionCriteria |
| Details |
1.Central Macular thickness >350microns
2.Retinal disorder other than Diabetic Retinopathy
3.Associated Glaucoma
4.Unwilling to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in Macular Volume
2.Change in Macular thickness of 3mm & 6mm zones of ETDRS grid |
1month, 3month & 6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in density of Hard exudates assessed
using Image J.
2.Conversion of non centre involving Edema to
Centre involving Edema.
3.Change in best corrected visual acuity
|
1month,3month & 6month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
30/08/2023 |
| 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="2"
Months="0"
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
|
This is a Prosective Randomised Control trial to evaluate the efficacy of Subthreshold Micropulse
focal yellow (577nm) laser on non centre involving CSME by comparison of change in macular
thickness and volume. It also compares its effect as compared to the Conventional laser . We will
carry out investigations like OCT, OCT-A ,FFA,FAF, Pseudocolor fundusphoto ,Before intervention
and at 1 month , 3 month and 6 month and compare the results. |