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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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