| CTRI Number |
CTRI/2024/07/070700 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser treatment] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Effectiveness, Safety of 2 types of Laser Treatments for Diabetic Macular Edema Not Involving the Central Area |
|
Scientific Title of Study
|
Comparison of the efficacy and safety of subthreshold micropulse laser Vs Conventional modified grid laser therapy for Non-centre involving 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 Anisha Agrawal |
| Designation |
Primary DNB Resident |
| Affiliation |
General Ophthalmology, Aravind Eye Hospital, Chennai |
| Address |
General Ophthalmology, Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9029010199 |
| Fax |
|
| Email |
agrawal.anisha@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puja Maitra |
| Designation |
Consultant, Vitreoretinal Department |
| Affiliation |
Vitreoretinal Department, Aravind Eye Hospital, Chennai |
| Address |
205, Vitreoretinal Services Department, Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9884541628 |
| Fax |
|
| Email |
puja.maitra@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Maitra |
| Designation |
Consultant, Vitreoretinal Services Department |
| Affiliation |
Vitreoretinal Services Department, Aravind Eye Hospital Chennai |
| Address |
205, Vitreoretinal Services Department, Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9884541628 |
| Fax |
|
| Email |
puja.maitra@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai, India. Pincode - 600077 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Chennai |
| Address |
Poonamallee High Road Opposite Saveetha Dental College Chennai 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Puja Maitra |
Aravind Eye Hospital, Chennai |
205, Vitreoretinal Services Department, 2nd floor, Aravind Eye Hospital, Poonamallee High Road, Numbal, Chennai - 600077
Chennai
TAMIL NADU |
9884541628
puja.maitra@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital Chennai Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
532nm modified grid laser |
Iridex 532 nm, 100 µm spot size, 1 spot size apart, duration 100 ms
|
| Intervention |
577 nm subthreshold micropulse laser (SMPL) |
Iridex 577 nm, Spot size: 150-200 micron, no spacing , 200ms pulse, 5% cycle, 50% of threshold power
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-centre involving DME – defined as SRF or IRF outside the central 1 mm of fovea
2. Treatment naïve for DME
3. ≥ 18years age
|
|
| ExclusionCriteria |
| Details |
1. Previous Intravitreal injections
2. Proliferative diabetic retinopathy requiring concurrent PRP. (Stable PDR patients post PRP are eligible for inclusion)
3. Concurrent other ocular comorbidities like glaucoma
4. Patients with Visually significant cataract
5. Uncontrolled hypertension, uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >12%), or recent (within 3 months) cerebrovascular accident (CVA), or myocardial infarction (MI).
6. One Eyed patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparing Change in macular volume and thickness between 2 groups
|
6 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparing Change in BCVA between 2 groups
Comparing Change in Autofluorescence and Visual Field Index HFA 24-2 between 2 groups
Any adverse event related to treatment
Number of patients requiring rescue treatment
Change in morphological characteristics
|
6 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| 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="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
|
Diabetic macular edema (DME) is thickening of the retina at the macular zone, which can affect the fovea and cause central loss of vision in patients with diabetes mellitus. DME is one of the leading causes of preventable blindness and visual acuity in diabetic population globally The current gold standard treatment of non centre involving DME is modified grid laser photocoagulation However, it had various potential side effects like enlargement of laser scars, scotomas, fibrosis, hemorrhage, accidental foveal injury, choroidal neovascular membrane (CNVM) formation. In the last decade, Subthreshold micropulse laser (SMPL) treatment has been intensively used for selected retinal diseases Subthreshold micropulse laser (SMPL) uses a series of short pulses rather than a short continuous delivery producing sublethal thermal effects, thereby stimulating retinal pigment epithelium (RPE). SMPL is a non destructive alternative treatment for DME and hence also has advantage of safely allowing multiple treatment sessions as needed. Major objective: To compare the efficacy and safety of 577 nm subthreshold micropulse laser (SMPL) in one arm versus 532 nm modified grid laser in the other arm
|