| CTRI Number |
CTRI/2020/06/025632 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Contrast sensitivity(CS) is the visual ability to distinguish an object from its background. It is affected in conditions like glaucoma, diabetic retinapathy, ARMD etc. The study aims to establish Normative data of CS in North Indian population using SPARCS. |
|
Scientific Title of Study
|
Establishment of Normative Database of Contrast Sensitivity in Indian Population using Spaeth and Richman Contrast Sensitivity test |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Bariya |
| Designation |
Junior Resident |
| Affiliation |
Department of Ophthalmology Government Medical College and hospital, sector 32, Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College and hospital , Sector 32,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9780068727 |
| Fax |
|
| Email |
soniabariya15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Ichhpujani |
| Designation |
Associate Professor |
| Affiliation |
Department of Ophthalmology Government Medical College and hospital, sector 32,Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College and hospital, sector 32,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501071591 |
| Fax |
|
| Email |
parul77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Bariya |
| Designation |
Junior Resident |
| Affiliation |
Department of Ophthalmology Government Medical College and hospital, sector 32, Chandigarh |
| Address |
Department of Ophthalmology Government Medical College and hospital, sector 32,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9780068727 |
| Fax |
|
| Email |
soniabariya15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology Government Medical College and hospital sector 32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and hospital Chandigarh |
| Address |
Department of ophthalmology
Government Medical College and hospital Chandigarh |
| 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 Sonia Bariya |
Government Medical College and hospital sector 32 Chandigarh |
Department of Ophthalmology
Block D, Level 3
Chandigarh
CHANDIGARH |
9780068727
soniabariya15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( GMCH 32, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non diabetic, non hypertensive individuals with BCVA more than 20/50 |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18years and less than 70 years
2. Either gender. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of incisional or laser eye surgery in the past 3 months
2. Any cause for visual impairment (e.g., glaucoma, cataract more than grade 2(LOCS), diabetic mellitus, Age Related Macular
Degeneration, etc.)
3. Any medical condition (e.g., cognitive impairment, Parkinson’s
disease, Alzheimer’s disease and any other neurological or musculoskeletal disease).
4. Best-corrected visual acuity (BCVA) of less than 20/50
5. Refractive error greater than +6 or −6 D; Astigmatism not more than +2D
6. Any sign of secondary glaucoma, significant media opacities, and a history of using topical/oral steroids. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain normative database of Contrast Sensitivity using SPARCS in North Indian population. |
At presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine affect of age, gender, astigmatism on peripheral and central contrast sensitivity |
At presentation |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/06/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Many contrast sensitivity(CS) tests have been developed in the past which could assess central CS. Spaeth and Richman Contrast sentivity test(SPARCS) asesses both central and peripheral CS.This study aims to establish normative database of Contrast sentivity in Indian population using SPARCS. |