| CTRI Number |
CTRI/2024/08/072812 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective data collection study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Collection of eye data from diabetic patients who were imaged on PLEX Elite Optical Coherence Tomography device for diabetic retinopathy evaluation |
|
Scientific Title of Study
|
A clinical study to collect Optical Coherence Tomography (OCT)
Angiography data from patients with a confirmed diagnosis of diabetes
who are being scanned on the ZEISS PLEX Elite 9000 OCT
Angiography device for diabetic retinopathy assessment.
|
| 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 Aditya Shreekant Kelkar |
| Designation |
Medical Director & specialist in cataract surgery |
| Affiliation |
National Institute of Ophthalmology |
| Address |
First Floor, Imaging Room, National Institute of Ophthalmology
376 Sind Society Bremen Square Ganesh Khind Road Aundh
Pune
Pune
MAHARASHTRA
411007
India |
| Phone |
912049014901 |
| Fax |
|
| Email |
adityapune4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GANESH BABU TC |
| Designation |
Head Clinical and Regulatory Affairs |
| Affiliation |
Carl Zeiss India (Bangalore) Private Limited |
| Address |
Carl Zeiss India (Bangalore) Private Ltd
Plot No 3 Jigani Link Road
Bommasandra Industrial Area
Bangalore 560099 India
Bangalore
KARNATAKA
560099
India |
| Phone |
8043438124 |
| Fax |
|
| Email |
ganesh.babu@zeiss.com |
|
Details of Contact Person
Public Query
|
| Name |
GANESH BABU TC |
| Designation |
Head Clinical and Regulatory Affairs |
| Affiliation |
Carl Zeiss India (Bangalore) Private Limited |
| Address |
Carl Zeiss India (Bangalore) Private Ltd
Plot No 3 Jigani Link Road
Bommasandra Industrial Area
Bangalore 560099 India
KARNATAKA
560099
India |
| Phone |
8043438124 |
| Fax |
|
| Email |
ganesh.babu@zeiss.com |
|
|
Source of Monetary or Material Support
|
| Carl Zeiss India (Bangalore) Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Carl Zeiss India Bangalore Private Limited. |
| Address |
Plot # 3, Jigani Link Road,
Bommasandra Industrial Area,
Bangalore - 560099 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Aditya Shreekant Kelkar |
National Institute of Ophthalmology |
First Floor, Imaging Room,
376 Sind Society Bremen Square Ganesh Khind Road
Aundh Pune 411007
Pune
MAHARASHTRA |
9689893887
adityapune4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of National Institute of Ophthalmology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, (3) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged 18 years and above with confirmed diagnosis of Type 1 and Type 2 Diabetes
2. Patients who consent to share their data for research and development purposes.
3. Patients with the following stages of DR and the respective distribution:
3.1 No DR (15%)
3.2 Mild NPDR (25%)
3.3 Moderate NPDR (25%)
3.4 Severe NPDR (25%)
3.5 Proliferative DR (10%)
3.6 Within the dataset of various DR stages, a small subset of the data shall fulfil the following
criterion:
3.6.1 Presence of Diabetic Macular Edema (DME) (5%)
|
|
| ExclusionCriteria |
| Details |
1. Patients who have not consented to share their data for research and development purposes.
2. Known history (in last 6 months from date of acquisition) of retinal artery or vein occlusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prospective study aims to gather OCTA image data and clinical information from 200 diabetic patients using the ZEISS PLEX Elite 9000 OCT Angiography device. The outcome of this study is data collection for research and development purposes. |
Time points are not applicable in this study as this is a data collection study only. The patients with confirmed diagnosis of diabetic retinopathy shall be enrolled in this study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
08/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Principal Investigator & Study Site:
Dr. Aditya Shreekant Kelkar,
Medical Director & specialist in cataract surgery
National Institute of Ophthalmology, 376, Sind Society, Bremen Square, Ganesh Khind Road,
Aundh, Pune - 411007
Study Design: A single center, prospective study, in which eligible patients with confirmed diagnosis of Diabetes
will be required to undergo imaging on the ZEISS PLEX Elite 9000 OCTA device as per the site
standard operating procedures for assessment of DR.
Diabetic patients will be recruited, screened for eligibility, and informed consent will be obtained
from those who meet the screening criteria.
The OCTA data from ZEISS PLEX Elite 9000 OCT Angiography device along with demographic
data and Clinical data will be collected. The data will be collected in an anonymized form, from
patients with confirmed diagnosis of diabetes as per the requirements mentioned in Annexure I,
who are being managed for diabetic retinopathy. The data will be collected from patients who
have consented to provide their angiography data and clinical data for use of research and
development purposes. The Principal Investigator shall ensure that the patient’s consent is
obtained before the data is collected from the patient.
OCTA data from following scanning protocols will be collected: 15x15 mm and/or 15x9 mm as
per the site’s SOP for imaging on ZEISS PLEX Elite 9000 device. The distribution for 15x15 mm
and 15x9 mm datasets has been provided in the Annexure I. In case, a patient exhibits diabetic
retinopathy in both eyes, the OCTA cube from each eye will be included in the patient’s dataset.
One OCTA data export per eye will be gathered from each patient. The assessment will involve
a review of each patient’s data to ensure image quality criteria, the Sponsor’s representative will
notify the Principal investigator about the image quality control measures. The conclusion of the
study will be determined by the last dataset transferred by the investigator, which undergoes
review and approval by the Sponsor for inclusion in the study. It is recommended that the gender distribution is uniform to avoid any skewness in the data. The
demographic parameters must be collected and populated as provided in the case record form.
Inclusion criteria: a. Male or female patients aged 18 years and above with confirmed diagnosis of Type 1
and Type 2 Diabetes b. Patients who consent to share their data for research and development purposes. c. Patients with the following stages of DR and the respective distribution:
• No DR (15%)
• Mild NPDR (25%)
• Moderate NPDR (25%)
• Severe NPDR (25%)
• Proliferative DR (10%)
Within the dataset of various DR stages, a small subset of the data shall fulfil the following.
criterion:
• Presence of Diabetic Macular Edema (DME) (5%)
Exclusion criteria: a. Patients who have not consented to share their data for research and development
purposes. b. Known history (in last 6 months from date of acquisition) of retinal artery or vein
occlusion.
|