| CTRI Number |
CTRI/2025/04/084351 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Other (Specify) [near vision glasses spherical non astigmatic correction] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of free near vision glasses (intervention) (spherical, non-astigmatic correction), in working age group (35 to 65 years) people having bilateral presbyopia in terms of increased household consumption and/or vision related quality of life in Mohammadi, India |
|
Scientific Title of Study
|
Randomised Controlled Trial of the Economic Advantages of Readers for Near vision in India |
| Trial Acronym |
EARN Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalinder Sabherwal |
| Designation |
Director Public Health |
| Affiliation |
Dr. Shroff Charity Eye Hospital |
| Address |
Department of Public Health,
Dr. Shroff Charity Eye Hospital
5027, Kedarnath Lane, Daryaganj, Delhi
Central DELHI 110002 India |
| Phone |
9910305208 |
| Fax |
|
| Email |
shalinder.sabherwal@sceh.net |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Bhagat |
| Designation |
Scientist Public Health Research |
| Affiliation |
Dr. Shroff Charity Eye Hospital |
| Address |
Department of Public Health,
Dr. Shroff Charity Eye Hospital
5027, Kedarnath Lane, Daryaganj, Delhi
Central DELHI 110002 India |
| Phone |
9868097889 |
| Fax |
|
| Email |
deepak.bhagat@sceh.net |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Bhagat |
| Designation |
Scientist Public Health Research |
| Affiliation |
Dr. Shroff Charity Eye Hospital |
| Address |
Department of Public Health,
Dr. Shroff Charity Eye Hospital
5027, Kedarnath Lane, Daryaganj, Delhi
Central DELHI 110002 India |
| Phone |
9868097889 |
| Fax |
|
| Email |
deepak.bhagat@sceh.net |
|
|
Source of Monetary or Material Support
|
| Dr. Shroff Charity Eye Hospital, Village Sahdeva, Gola Shahjahanpur Road, Mohammadi, Lakhimpur Kheri, Uttar Pradesh, India, Pin Code 262804 |
| London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street London, United Kingdom, Pin code WC1E 7HT, Contact 44 (0)20 7636 8636 |
|
|
Primary Sponsor
|
| Name |
London School of Hygiene and Tropical Medicine |
| Address |
Keppel Street London, United Kingdom, Pin Code WC1E 7HT, Contact 44 (0)20 7636 8636 |
| Type of Sponsor |
Research institution |
|
|
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 Deepak Bhagat |
Dr Shroff Charity Eye Hospital |
Room No 1, Block B, Second Floor, Department of Public Health Kheri UTTAR PRADESH |
9868097889
deepak.bhagat@sceh.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Shroff Charity Eye Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with bilateral presbyopia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control arm not given free near vision glasses at baseline |
At baseline, Control arm will NOT be given free near vision glasses. However, at the end of Trial Follow-up period, they will be given free near vision glasses (spherical, non-astigmatic correction), appropriate for their degree of presbyopia. |
| Intervention |
free near vision glasses, spherical, non-astigmatic correction |
Intervention arm will be given free near vision glasses, spherical, non-astigmatic correction, appropriate for their degree of presbyopia. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Bilateral presbyopia and do not currently own or use glasses for near vision
(2) Adults aged between 35 and 65 years
(3) resident in the locality where the study is being conducted which means lived there for more than 6 months and intend to continue living there for the next two years
(4) Provide informed consent and agreement to be randomly allocated to one of the two study arms |
|
| ExclusionCriteria |
| Details |
1. Presbyopia and owns near vision glasses (met need or partially met need)
2. Pinhole distance VA of worse than 6/12 in the better eye
3. Current illness or incapacity preventing the individual from working.
4. Inability to communicate.
5. Any occupation with formal guidance requiring safety glasses for near work.
6. Another member of the household has already been enrolled into the trial. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Household Consumption and Vision Related Quality of Life |
at 12 months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Employment Status and characteristics |
at 12 months and 24 months |
| Self-reported productivity (presenteeism |
at 12 months and 24 months |
| Self-reported income sufficiency |
at 12 months and 24 months |
| Self-reported individual income (from employment and production) |
at 12 months and 24 months |
| Health related Quality of Life: EQ5D with vision bolt-on question |
at 12 months and 24 months |
|
|
Target Sample Size
|
Total Sample Size="10000" Sample Size from India="10000"
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)
|
21/04/2025 |
| 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="4" Months="6" 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
|
This is a prospective, single-masked, parallel group, two-arm individually randomised controlled trial (RCT), embedded within the community-based screening programme which is currently underway in Shahjahanpur and Lakhimpur Kheri districts, Uttar Pradesh, India. We aim to recruit adults between the ages 35 and 65 years, who have been identified as having presbyopia during screening, and do not own near vision glasses. Trial participants will be randomised to either the intervention arm - whereby individuals will be given free near vision glasses at the start of the study, or the control arm – whereby individuals will be given free near vision glasses at the end of the trial follow-up period (2 years). The co-primary outcomes are household consumption at 12 months and vision related quality of life at 12 months. Our secondary analysis will examine if the provision of near vision glasses to people of working age with presbyopia leads to: (i) increased individual income; (ii) increased household consumption, individual income, and/or workplace productivity in those who work in near vision intense/dependent occupations (occupational sub-group analysis). The findings will be written up for peer-reviewed publication and actively shared with key stakeholders. If the intervention proves effective it will inform policy and may catalyse funding to improve access to this relatively cheap and potentially cost-effective intervention. |