| CTRI Number |
CTRI/2023/03/050981 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Suprachoroidal route of drug (Triamcinolone)delivery ] |
| Study Design |
Other |
|
Public Title of Study
|
TREATMENT OF NON INFECTIOUS UVEITIS THROUGH EYE INJECTION |
|
Scientific Title of Study
|
TO STUDY THE ROLE OF SUPRACHOROIDAL INJECTION TRIAMCINOLONE IN NON-INFECTIOUS UVEITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RITU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
127/445 w-block , Keshav Nagar, Kanpur
DEPARTMENT OF OPHTHALMOLOGY, WARD 9, LASER ROOM, GSVM MEDICAL COLLEGE, SWAROOP NAGAR, KANPUR, UTTAR PRADESH, 208002
Kanpur Nagar
UTTAR PRADESH
208014
India |
| Phone |
8887578040 |
| Fax |
|
| Email |
dr.ritukumar05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PARUL SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, WARD 9, LASER ROOM, KANPUR NAGAR, 208002
DEPARTMENT OF OPHTHALMOLOGY, WARD 9, LASER ROOM , 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
|
| Fax |
|
| Email |
parulsingh1406@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RITU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
127/445 W-BLOCK, KESHAV NAGAR, KANPUR
DEPARTMENT OF OPHTHALMOLOGY, WARD 9, LASER ROOM, LLRH GSVM MEDICAL COLLEGE, SWAROOP NAGAR, KANPUR, UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208014
India |
| Phone |
8887578040 |
| Fax |
|
| Email |
dr.ritukumar05@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM medical college,Kanpur |
|
|
Primary Sponsor
|
| Name |
GSVM MEDICAL COLLEGE |
| Address |
GSVM MEDICAL COLLEGE, SWAROOP NAGAR, KANPUR, UTTAR PRADESH |
| 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 |
| Ritu |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
DEPARTMENT OF OPHTHALMOLOGY, WARD 9, LASER ROOM, KANPUR
Kanpur Nagar
UTTAR PRADESH |
8887578040
dr.ritukumar05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITEE GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H309||Unspecified chorioretinal inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SUPRACHOROIDAL INJECTION TRIAMCINOLONE IN PATIENTS OF NON-INFECTIOUS UVEITIS |
SINGLE SUPRACHOROIDAL INJECTION TRIAMCINOLONE 0.1 ml GIVEN UNDER ASEPTIC PRECAUTIONS AND POST INJECTION FOLLOW UP FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Newly diagnosed patients of non-infectious anterior uveitis. (2) Newly diagnosed patients of non-infectious intermediate uveitis. (3) Newly diagnosed patients of non-infectious posterior uveitis |
|
| ExclusionCriteria |
| Details |
(1) Patients not willing to participate or ready for follow up.
(2) Patients with uncontrolled blood sugar.
(3) Patients with any ocular disease other than uveitis.
(4) Patients contraindicated for suprachoroidal injection eg. thinned sclera, scleritis, staphylococcus.
(5) Patients of hypersensitivity for Triamcinolone.
(6) Patients diagnosed of any other posterior segment pathologies. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) BCVA
2) Slit lamp examination
3) Intra ocular pressure
|
3 days after injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BCVA
Slit lamp examination
Intraocular pressure
Indirect ophthalmoscopic assessment of fundus |
15days after injection |
BCVA
Slit lamp examination
Intraocular pressure
Indirect ophthalmoscopic assessment of fundus
USG B Scan assessment of posterior segment
OCT to assess resolution of Macular oedema |
1month after injection |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2023 |
| 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="0"
Months="6"
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
|
This is Randomised prospective study , to assess the role of suprachoroidal injection of Triamcinolone in patients of non- infectious anterior, non-infectious intermediate and non-infectious posterior uveitis. Primary outcome will be BCVA improvement in 3-15 days. |