| CTRI Number |
CTRI/2025/03/083170 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Experimental Study |
| Study Design |
Other |
|
Public Title of Study
|
How Lighting Conditions Affect Eye Focus When Reading a Book |
|
Scientific Title of Study
|
Impact of Different Illumination Levels on Ocular Accommodation in Healthy Adults During Paper-based Reading: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08420961195 |
| Fax |
|
| Email |
vishalbiswas45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh
UTTAR PRADESH
203201
India |
| Phone |
08420961195 |
| Fax |
|
| Email |
vishalbiswas45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh
UTTAR PRADESH
203201
India |
| Phone |
08420961195 |
| Fax |
|
| Email |
vishalbiswas45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh, 203201 |
|
|
Primary Sponsor
|
| Name |
NonApplicable |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Roshni Majumder |
Noida International University |
Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
7086151146
roshni.majumder98@gmail.com |
| Vishal Biswas |
Noida International University |
Refraction Lab, Newton Block, Department of Optometry, School of Allied Health Sciences, Noida International University, Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
8420961195
vishalbiswas45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Noida International Institute of Medical Sciences of |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human participants who all can read. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. University adults aged 17-24 years
2. Aided visual acuity 20/20 for both near and distance
3. Normal binocular vision parameters |
|
| ExclusionCriteria |
| Details |
1. Presence of ocular diseases or conditions affecting accommodation & dry eye
2. History of ocular surgery
3. Current use of medications affecting ocular function
4. Not willing to participate
5. Contact lens wearer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will evaluate how different lighting levels affect ocular accommodation during paper-based reading. Accommodation amplitude, lag, and facility will be measured using autorefractors or dynamic retinoscopy, while visual fatigue symptoms like eye strain, headache, and discomfort will be assessed through questionnaires. The goal is to identify optimal lighting to improve accommodation efficiency and visual comfort in healthy adults. |
Base line- 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this study will focus on additional visual & reading performance parameters influenced by different illumination levels. These include reading speed & comprehension, assessed through standardized reading tests, as well as subjective visual comfort, measured via validated questionnaires. Additionally, pupil diameter changes & blink rate may be recorded to analyze physiological responses to lighting variations. The study will also evaluate the persistence of visual fatigue over time by tracking accommodative recovery post-reading. These outcomes will provide a broader understanding of how lighting impacts overall visual efficiency & reading performance in healthy adults. |
1. Base line- 1 week |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
26/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
This experimental study aims to evaluate the impact of different illumination levels on ocular accommodation during paper-based reading in healthy adults. Participants will undergo reading tasks under varying light intensities while assessing changes in accommodative response, visual fatigue, and reading performance. Primary outcomes include accommodative amplitude, lag, and facility, while secondary outcomes focus on reading speed, comprehension, pupil dynamics, and subjective discomfort. Measurements will be taken before, during, and after reading, with short-term recovery assessments. Findings will help determine optimal lighting conditions to minimize visual strain and enhance reading efficiency, contributing to improved environmental lighting recommendations. |