| CTRI Number |
CTRI/2024/06/069496 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To Correlate changes in contrast sensitivity with higher order aberrations in patients of Computer Vision Syndrome. |
|
Scientific Title of Study
|
Correlation of central and peripheral contrast
sensitivity with higher order aberrations in
computer vision syndrome |
| 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 Varnika Aditi Singh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Ophthalmology D block Level 3 Government Medical
College and Hospital, Sector-32B,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
varnikaaditisingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Ichhpujani |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Ophthalmology D block Level 3 Government Medical
College and Hospital, Sector-32B,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501071591 |
| Fax |
|
| Email |
parul77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Ichhpujani |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Ophthalmology D block Level 3 Government Medical
College and Hospital, Sector-32B,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501071591 |
| Fax |
|
| Email |
parul77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector-32B, Chandigarh
160030
India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital, Sector-32B, Chandigarh
160030
India |
| Type of Sponsor |
Government 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 Varnika Aditi Singh |
Government Medical College and Hospital |
Department of Ophthalmology D block Level 3 Government Medical
College and Hospital, Sector-32B, Chandigarh
160030
India
Chandigarh
CHANDIGARH |
9872390418
varnikaaditisingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH,Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
digital device users |
| Patients |
(1) ICD-10 Condition: H189||Unspecified disorder of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
SUBJECT SELECTION
Group 1: Normal Controls
Group 2: Patients with Computer Vision Syndrome
INCLUSION CRITERIA FOR GROUP 1
1. Age more than 18 and less than 40 years, either gender
2. Best corrected visual acuity of 6/6 and near acuity of N6.
3. No signs or symptoms of CVS
9
INCLUSION CRITERIA FOR GROUP 2
1. Age more than 18 and less than 40 years, either gender
2. Best corrected visual acuity of 6/6 and near acuity of N6.
3. Having a score of more than 6 in the CVS-Q questionnaire |
|
| ExclusionCriteria |
| Details |
1. Contact lens use
2. Patients with history of incisional or laser eye surgery
3. Any cause for visual impairment (e.g., glaucoma, cataract more than grade 2 or higher
using LOCS III grading (Annexure 3), diabetic retinopathy, Age Related Macular
Degeneration, etc.) or media opacities.
4. Patients with amblyopia; strabismus; anisometropia; refractive errors higher than 6 D
myopia, 4 D hyperopia, or 4 D astigmatism
5. Any medical condition which in the investigator‟s opinion would preclude the patient
from providing reliable and valid data (e.g., cognitive impairment, Parkinson‟s disease,
Alzheimer‟s disease and any other neurological or musculoskeletal disease). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare central and peripheral contrast sensitivity in patients with computer vision
syndrome (with and without dry eye disease) and normal controls |
in a period of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate changes in contrast sensitivity with higher order aberrations and compare
them in between patients with and without CVS. |
in a period of 12 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
06/02/2025 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Computer vision syndrome/digital eye strain has drastically increased due to a recent rise in electronic devise use post the COVID era.Infrequent blinking due to constant device use leads to tear film instability causing dry eye disease and inducing higher order aberrations which affect the contrast sensitivity and overall affecting the quality of vision. |