| CTRI Number |
CTRI/2023/03/050271 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of Diabetic Retinopathy |
|
Scientific Title of Study
|
To study the role of suprachoroidal dexamethasone injection in patients with Diabetic Retinopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANG CHAURASIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
DEPARTEMENT OF OPHTHALMOLOGY , WARD NO 9 , LASER ROOM
GSVM MEDICAL COLLEGE , SWAROOP NAGAR , KANPUR , UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
|
| Fax |
|
| Email |
lavi039@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PERWEZ KHAN |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
DEPARTEMENT OF OPHTHALMOLOGY , WARD 9 , LASER ROOM , LLRH
WARDEN BUNGALOW, GSVM MEDICAL COLLEGE, SWAROOP NAGAR, KANPUR, UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
|
| Fax |
|
| Email |
perwezkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIVANG CHAURASIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GANESH SHANKAR VIDYARTHI MEDICAL COLLEGE |
| Address |
DEPARTEMENT OF OPHTHALMOLOGY , WARD NO 9 , LASER ROOM , LLRH
GSVM MEDICAL COLLEGE , SWAROOP NAGAR , KANPUR , UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
|
| Fax |
|
| Email |
lavi039@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| SHIVANG CHAURASIA |
GSVM MEDICAL COLLEGE |
DEPARTEMENT OF OPHTHALMOLOGY , WARD 9 , LASER ROOM
Kanpur Nagar
UTTAR PRADESH |
9889826961
lavi039@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXAMETHASONE INJECTION |
TAKING ASEPTIC PRECAUTIONS UNDER TOPICAL ANESTHESIA SUPRACHOROIDAL INJECTION OF 0.1ML DEXAMETHASONE BY INDIGENOUSLY DESGINED 20G STEEL SLEEVE AND INJECTED BY 26G NEEDLE. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS DIAGNOSED WITH TYPE 2 DIABETES MELLITUS WITH MILD AND MODERATE DIABETIC RETINOPATHY |
|
| ExclusionCriteria |
| Details |
PATIENTS NOT WILLING TO PARTICIPATE OR READY FOR FOLLOW UP.
PATIENTS HAVING SEVERE DIABETIC RETINOPATHY,PROLIFERATIVE DIABETIC RETINOPATHY AND DIABETIC MACULAR EDEMA.
PATIENTS WITH UNCONTROLLED DIABETES.
PATIENTS WITH ANY OCULAR INFECTION,RAISED INTRAOCULAR PRESSURE,ANY CORNEAL PATHOLOGY,THINNED SCLERA,SCLERITIS,STAPHYLOMA OR ANY OTHER ANTERIOR SEGMENT PATHOLOGY EXCEPT PSEUDOPHAKIC PATIENTS.
PATIENTS DIAGNOSED OF ANY OTHER RETINAL OR VITREOUS PATHOLOGIES EXCEPT DIABETIC RETINOPATHY. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN VISUAL ACUITY |
3-6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RAISED INTRAOCULAR PRESSURE |
1-5 DAYS |
| CHOROIDAL/RETINAL DETACHMENT |
1 DAY |
| CATARCT |
6 MONTHS- 1 YEAR |
| DECREASE IN VISUAL ACUITY |
1 DAY- 1YEAR |
| VITRITIS/ ENDOPHTHALMITIS |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
02/03/2023 |
| 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="1"
Months="0"
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
|
TO DETERMINE THE ROLE OF SUPRACHOROIDAL DEXAMETHASONE INJECTION IN PATIENTS WITH DIABETIC RETINOPATHY. WE WILL RECRUIT PATIENTS DIAGNOSED WITH DIABETES MELLITUS AND GRADE THEM INTO VARIOUS STAGES OF DIABETIC RETINOPATHY AFTER PERFORMING STANDARDISED INVESTIGATIONS.WE WILL ENROLL PARTICIPANTS AS PER OUR INCLUSION AND EXCLUSION CRITERIA. AFTER TAKING PROPER CONSENT AND TAKING APPROPRIATE ASEPTIC PRECAUTIONS IN OUR OT WE WILL INJECT 0.1ML DEXAMETHASONE VIA SUPRACHOROIDAL ROUTE UNDER TOPICAL ANESTHESIA.THEN WE WILL FOLLOW UP PATIENTS REGULARLY TO LOOK FOR THE CHANGES IN DISEASE STAGE (IMPROVEMENT/HALT/PROGRESSION) ALONGWITH POSSIBLE ADVERSE EFFECTS THAT WE CAN ANTICIPATE IN OUR INTERVENTION. |