| CTRI Number |
CTRI/2024/09/073285 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study to see diabetic retinopathy changes by a maschine after cataract surgery |
|
Scientific Title of Study
|
An interventional study to see optical coherence tomography angiography biomarkers changes after cataract surgery on macula in diabetic retinopathy with no 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 Kavita Bajiya |
| Designation |
M.S opthalmology resident |
| Affiliation |
SMS Medical College Jaipur Rajasthan |
| Address |
Department of Ophthalmology, SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
9784359963 |
| Fax |
|
| Email |
kavitamedico25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Parwal |
| Designation |
Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Ophthalmology, SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107474333 |
| Fax |
|
| Email |
sandeepparwal1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Parwal |
| Designation |
Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Ophthalmology, SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107474333 |
| Fax |
|
| Email |
sandeepparwal1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ophthalmology ,Charak Bhawan ,SMS Medical College Jaipur,Rajasthan India Pin code -302004 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Kavita Bajiya |
SMS medical college and hospital jaipur |
Charak Bhawan Eye OT and eye OPD
dipartment of Ophthalmology room no -8 ,division -Retina ,Jaipur RAJASTHAN India 302004
Jaipur
RAJASTHAN |
9784359963
kavitamedico25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, S.M.S. Medical College And Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: H251||Age-related nuclear cataract, (3) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cataract surgery(phacoemulsification) |
cataract surgery done in 50-80yr age diabetic and nondiabetic patients |
| Comparator Agent |
Optical coherence tomography angiography |
OCTA biomarkers MT,SCPVD, SCPPD, FAZ are compare in diabetic and non diabetic patients before doing cataract surgery and after 3 months cataract surgery. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
(A) For Diabetic Patients :
1. Diabetic retinopathy patients with immature senile cataract who require phacoemulsification surgery
2. Intraocular pressure between 10-21 mmHg
3. Given written informed consent
4. Age between 50-80 yrs
(B) For Non diabetic patients (control group):
1. Patients with immature senile cataract who require phacoemulsification surgery
2. Intraocular pressure between 10-21 mmHg
3. Given written informed consent
4. Age between 50-80 yrs
|
|
| ExclusionCriteria |
| Details |
Eyes with Diabetic Macular Edema .
Eyes with Intraocular pressure higher than 21mmHg.
Eyes with mature , posterior sub capsular and posterior polar cataract
History of retinal laser or intravitreal injection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare these parameters in diabetic patients and non diabetic patients before and after cataract surgery using Optical Coherence Tomography Angiography-:
a) Macular thickness
b) Superficial capillary vessel density
c) Superficial capillary plexus perfusion density
d) Chorodial thickness
e) Foveal avascular zone
|
baseline before cataract surgery
7 days
1 month
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To see correlation between macular thickness and superficial capillary plexus (SCP) vessel density that occurs due to cataract surgery.
2. To see correlation of macular thickness and superficial capillary plexus (SCP) vessel density with Best Corrected Visual Acuity.
3. To see correlation between foveal avascular zone and best corrected visual acuity.
|
baseline before cataract surgery
7 days
1 month
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
13/09/2024 |
| 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
|
Diabetes is a most prevelent disease affecting 425million people worldwide. Diabetes causes many ocular complications., such as cataract and diabetic retinopathy which are the main causes of decreased vision in diabetic patients and often coexists. The principle pathogenesis of diabetic retinopathy is the breakdown of the BRB. In this study we used OCTA to asses the macular thickness , superficial and deep vascular densities ,FAZ , and chorodial thickness in diabetic and nondiabetic patients after cataract surgery. |