| CTRI Number |
CTRI/2025/06/088327 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of different types of LED lights on reading tasks in people with reduced visual acuity. |
|
Scientific Title of Study
|
The Impact Of Lighting On Visual Performance In Individuals With Visual Impairments. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanila Lawrance |
| Designation |
Assistant Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanila Lawrance |
| Designation |
Assistant Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanila Lawrance |
| Designation |
Assistant Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
8138847848 |
| Fax |
|
| Email |
sanilalawr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Varthur Main Road,Kundalahalli,Bengaluru, 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 |
| Dr Namratha |
Sankara Eye Hospital |
Kundalahalli signal, Varthur Main Road,Bengaluru 560037
Bangalore
KARNATAKA |
9986266576
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: H542||Low vision, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with visual Impairment
Visual Acuity from mild to moderate |
|
| ExclusionCriteria |
| Details |
Patients who have severe visual impairment and who cannot perform the visual assessments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Near visual acuity, contrast and reading speed evaluated. |
Baseline reading only taken. No follow ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the Preferable lighting conditions in visually impaired with conditions of central field defects , peripheral field defects and overall field defects and To Understand effect of Glare on Visual Acuity |
One Day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
12/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/06/2025 |
| 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) |
Open to Recruitment |
|
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
|
The Project Titled The Impact Of Lighting On Visual Performance in Individuals With Visual Impairments aims to Evaluate How different Lighting Conditions Affect Visual Functions Such As Visual Acuity, Contrast Sensitivity and Reading Speed in individuals with Mild to Moderate Visual impairment. The study will use Clinical Assessments including Near Visual Acuity and Reading Speed using MNREAD, Contrast Sensitivity using Pelli Robson Chart and Glare Testing Using Brightness Acuity Test under Three DIfferent Lighting Conditions. By identifying Preferred Lighting Environments for Various Types of Visual Field Defects, the Study Seeks to Provide Practical Guidance for optimizing lighting in Homes and Work Place, Ultimately Enhancing Independence and Quality of Life for Visually impaired. |