| CTRI Number |
CTRI/2025/08/092227 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Blue on Yellow Chart as a Screening Tool for Early Detection of Diabetic Macular Edema |
|
Scientific Title of Study
|
Evaluation Of Blue On Yellow Chart as a Screening Tool for Early Detection of 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 Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Dept. of Optometry, Sankara Academy of Vision, Sankara Eye Hospital, Varthur Main Road, Bengaluru
Dept. of Optometry, Sankara Academy of Vision, Sankara Eye Hospital, Varthur Main Road, Bengaluru 560037 Karnataka, India
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@sankaraeye.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Dept. of Optometry, Sankara Academy of Vision, Sankara Eye Hospital, Varthur Main Road, Bengaluru
Dept. of Optometry, Sankara Academy of Vision, Sankara Eye Hospital, Varthur Main Road, Bengaluru Karnataka India 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Dept. of Optometry, Sankara Academy of Vision, Sankara Eye Hospital, Varthur Main Road, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Varthur Main Road,Kundalahalli Signal,Bangalore,Karnataka,India 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,Varthur Main Road,Kundalahalli Signal,Bangalore,Karnataka,India 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrNamratha Hegde |
Sankara Eye Hospital |
Department Of Optometry,Sankara College Of Optometry,Sankara Eye Hospital,Varthur Main Road,Kundalahalli Gate,Bangalore.
Bangalore
KARNATAKA |
09986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H30-H36||Disorders of choroid and retina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Conformed Diagnosis of Diabetic Macular Edema in atleast one eye.
Literate patient who can able to read Diatance and Near Vision chart in english |
|
| ExclusionCriteria |
| Details |
Any Ocular Diseases that could affect Visual Acuity or Color Perception-Optic neuropathy or with Severe Dry Eye |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will provide evidence on the efficacy of the Blue on Yellow Visual Acuity CHart in detecting Diabetic Macular Edema,much before the patient perceives symptoms. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Findings may lead to a more sensitive and user friendly Screening Tool for monitoring Macular Edema |
One time |
|
|
Target Sample Size
|
Total Sample Size="326"
Sample Size from India="326"
Final Enrollment numbers achieved (Total)= "186"
Final Enrollment numbers achieved (India)="186" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
06/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
An Observational study on Evaluation of Blue on Yellow Chart
as a Screening Tool for Early Detection of Diabetic Macular Edema with an
Objective of to Evaluate the Sensitivity and Specificity of a Blue on Yellow
Distance and Near Visual acuity chart in detecting the Diabetic Macular Edema
and to Correlate the Visual Acuity measured with novel Blue on Yellow chart
with the thickness measured with OCT. The patients are recruited based on the
inclusion and exclusion criteria set.The initial assessments include
Demographic data,Detailed Medical and Ophthalmic history,BCVA Measurment with
LogMAR,Color vision,visual acuity with Blue on Yellow Distance and Near vision
chart,Anterior and Posterior segment evaluation,OCT for Macular Thickness. This study Aims to Evaluate the Effectiveness of Blue on
Yellow Visual Acuity chart for Distance and Near as a Screening Tool for
Diabetic Macular Edema. |