| CTRI Number |
CTRI/2026/01/101019 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Screen brightness standardization,Repeated Measures ANOVA ] |
| Study Design |
Other |
|
Public Title of Study
|
The Effect On Eyesight Due To Screen-time at Constant Brightness In Young Adults |
|
Scientific Title of Study
|
The Effect On Visual Function and Tear Film in Young Adults Due To Screen-time After Brightness Standardization |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eesha |
| Designation |
MBBS Student (Batch of 2021) |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
MBBS, Ground Floor, K.S. Hegde Medical Academy, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8986009905 |
| Fax |
|
| Email |
eesha.21uml046@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maria Loraine Lydia |
| Designation |
Senior Resident (Department of Opthalmology) |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
Ground Floor, OPD 8, Ophthalmology, 3rd Cabin, K.S. Hegde Medical Academy, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6361495746 |
| Fax |
|
| Email |
drmaria.lydia@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maria Loraine Lydia |
| Designation |
Senior Resident (Department of Opthalmology) |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
Ground Floor, OPD 8,Ophthalmology, 3rd Cabin, K.S. Hegde Medical Academy, Deralakatte, Ullal, Mangalore
KARNATAKA
575018
India |
| Phone |
6361495746 |
| Fax |
|
| Email |
drmaria.lydia@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K.S. Hegde Medical Academy |
| Address |
Deralakatte, Ullal, Mangalore, Dakshina Kannada District, 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 Maria Loraine Lydia |
K.S. Hegde Medical Academy (Department of Ophthalmology) |
Ground Floor, K.S. Hegde Medical Academy, Deralakatte, Ullal, Mangalore
Dakshina Kannada
KARNATAKA |
6361495746
drmaria.lydia@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K.S. Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Visual function and tear film |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Standardized Brightness x24 hours x 7 days x 8 weeks |
(~150cd/m^2) Standardization of screen brightness for smartphones, tablets and laptops of all participants |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
- Refractive status emmetropia (between –0.50D to +1.00D or low-to-moderate myopia, –0.50D to –3.00D)
- Refractive astigmatism less than 0.50D cylinder
- Corrected visual acuity of zero log MAR (or better) in both eyes
- Normal binocular vision and accommodative function. |
|
| ExclusionCriteria |
| Details |
-A minimum screen-time of 2 hours/day
-History of ocular (including refractive) surgery
-Current ocular pathology(e.g. cataracts, glaucoma, AMD, corneal disease, diabetic retinopathy, conjunctivitis)
-Autoimmune diseases or medications (e.g. isotretinoin, anticholinergics) affecting vision or tear film
-Recent contact lens wear(24-48 hours)
-Pregnancy (to exclude hormonal influences on tear film) |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
correlation between
-change in visual function parameters
-screen-time |
week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
contrast sensitivity
|
baseline, week 1, week 4, week 8 |
color sensitivity,
|
baseline, week 1, week 4, week 8 |
Tear Film Breakup Time
|
baseline, week 1, week 4, week 8 |
Schirmer test values
|
baseline, week 1, week 4, week 8 |
| best corrected visual acuity |
baseline, week 1, week 4, week 8 |
| device logged screen-time in hours/week for all devices owned by each participant |
daily |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
01/02/2026 |
| 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="0"
Months="2"
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
|
Hypothesis:
To determine whether standardization of brightness levels produces measurable changes in visual
function (contrast sensitivity, color sensitivity and visual acuity) and tear-film function and if these
changes correlate with screen-time. Objectives:
1. To determine change in BCVA over 8 weeks after brightness is standardized. 2. To determine change in contrast sensitivity over 8 weeks after brightness is standardized. 3. To determine change in color sensitivity over 8 weeks after brightness is standardized. 4. To determine change in tear film over 8 weeks after brightness is standardized. 5. To correlate changes in BCVA, contrast sensitivity, color sensitivity and tear film with screen-time post
brightness standardization.
Importance of the study
To determine if excessive screen-time is detrimental to eyesight so individuals may attempt to curtail the use of digital devices. (for example, by using paperback textbooks instead of soft copies/pdfs on tablets/ipads) |