| CTRI Number |
CTRI/2024/09/073686 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of effect of intravitreal triamcinolone with phacoemulsification and stand-alone surgery in diabetic patients |
|
Scientific Title of Study
|
Comparative evaluation of combined phacoemulsification surgery and low-dose intravitreal triamcinolone acetonide versus stand-alone surgery in patients of cataract with 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 |
Adithya R Nath |
| Designation |
Junior Resident |
| Affiliation |
Guru Nanak Eye Centre, Maulana azad Medical college |
| Address |
Department of Ophthalmology,
Guru Nanak Eye Centre,
Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
08590254596 |
| Fax |
|
| Email |
adithyarnath1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Meenakshi Thakar |
| Designation |
Professor |
| Affiliation |
Guru Nanak Eye Centre, Maulana azad Medical college |
| Address |
Guru Nanak Eye Centre,
Maulana azad medical college, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9868001242 |
| Fax |
|
| Email |
meenakshithakar147@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adithya R Nath |
| Designation |
Junior Resident |
| Affiliation |
Guru Nanak Eye Centre, Maulana azad Medical college |
| Address |
Guru Nanak Eye Centre, Maulana azad Medical college, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
08590254596 |
| Fax |
|
| Email |
adithyarnath1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology,
Maulana Azad Medical College and Associated G.N.E.C, New Delhi, India, PIN-110002 |
|
|
Primary Sponsor
|
| Name |
Prof Meenakshi Thakar |
| Address |
Director Professor
Department of Ophthalmology
Maulana Azad Medical College and Associated G.N.E.C, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAdithya R Nath |
Guru Nanak Eye Centre |
Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002
New Delhi
DELHI |
8281540833
adithyarnath1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad Medical College, New Delhi |
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 |
| Intervention |
Combined Phacoemulsification with Intravitreal Triamcinolone acetonide injection |
Intravitreal injection of Triamcinolone acetonide 2mg in 0.05 mL, in diabetic retinopathy patients undergoing cataract surgery, single injection over a period of 3 months |
| Comparator Agent |
Stand alone phacoemulsification surgery |
Stand alone phacoemulsification surgery in diabetic retinopathy patients without intravitreal Triamcinolone acetonide injection |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients above 20 years of age with type 2 diabetes mellitus having NPDR or treatable PDR according to ETDRS classification, with visually significant cataract surgery |
|
| ExclusionCriteria |
| Details |
Patients with other ocular co-morbidities,
Complicated cataract |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in central macular thickness post intervention |
Change in central macular thickness at 1 month and 3 month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in intraocular pressure |
1 week and weekly if high |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/09/2024 |
| 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="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
|
It is a randomised prospective interventional study to compare the effect of intravitreal triamcinolone acetonide in central macular thickness in diabetic retinopathy patients undergoing phacoemulsification surgery with stand-alone phacoemulsification surgery |