Reading Glass on Livelihoods and Quality of Life in Rural Bangladesh

NCT03719196 | Completed DMC

• 1 other identifier: RED_101
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

The issue of uncorrected Presbyopia is an emerging health and livelihoods problem in Bangladesh. Presbyopia is easily corrected with an appropriate pair of reading glasses. Non-governmental organizations and government agencies have been working in many emerging markets, including Bangladesh, to increase eyeglass coverage among low-income adults by introducing basic vision screening and the dispensing of reading glasses at the community level. While vision screening is typically considered a health intervention, the primary motivation of these organizations and government agencies is to correct blurry vision with the intention of improving adults' income earning potential. VisionSpring and BRAC (previously known as Bangladesh Rural Advancement Committee) are two such NGOs who are partnering to implement a "Reading Glasses for Improved Livelihoods" program. VisionSpring is a social enterprise with a mission to increase access to affordable eye care and glasses in low-income settings. BRAC is an international development organization dedicated to alleviating poverty by empowering the poor. VisionSpring and BRAC have initiated a Randomized Control Trial to assess the economic and social impact that reading glasses may have on individuals that earn less than $4 a day. The study hypothesizes that post-intervention, the adoption of reading glasses will increase productivity related to paid work, and will enhance the vision-related quality of life of adults with Presbyopia. This experimental trial is designed to test the aforementioned hypotheses. In March 2017 a census survey was conducted in 59 villages of adults aged ≥35 and ≤65 years old in order to identify individuals with uncorrected presbyopia who would be eligible for enrollment in the study intervention. Following household visual acuity screenings, study participants were selected for enrollment. Randomization was conducted at the household level. Based on the inclusion criteria, a total of 824 random households were surveyed at the baseline. Following completion of the baseline survey, in August 2017 the treatment group was given reading glasses free-of-cost. The endline survey will be conducted in March 2018, eight months from the baseline. Although some income-related outcomes may take more time to manifest, it is anticipated that the wearing of glasses precipitates changes in a relatively short time frame. The control group will receive reading glasses at the conclusion of the endline survey.

Conditions

Presbyopia

Keywords

Presbyopia; Quality of life; Reading glass; Productivity

Outcome Measures

Primary Outcomes (1)

• Income (Bangladeshi Taka)

  Each participant's income data will be captured before and after the intervention by structured questionnaire (e.g: how much taka you earned in last 30 days?). The data will then be calculated before and after the intervention (8 months period) and will be compared between intervention and control group participants to see the difference.

  7 to 8 months.

Secondary Outcomes (3)

• Secondary outcome 1: Difficulties in performing daily wise task:

  7 to 8 months.

• Quality of vision: Likert scale

  7 to 8 months.

• Discomfort in functioning social activities

  7 to 8 months.

Study Arms (2)

Reading glass provided

EXPERIMENTAL

Randomization took place after conducting the census survey. Participants were selected based on the inclusion criteria. 423 random households were surveyed at the baseline. These households have been given reading glasses free of cost.

Other: Reading glass

Non-reading glass

NO INTERVENTION

A total of 824 households were surveyed at the baseline survey. Among them, 423 households have been provided reading glasses. The 401 remaining households were not given reading glasses during the baseline survey. The endline survey will be conducted in March 2018. Upon completing the endline survey, the non-reading glasses group will be provided reading glasses.

Interventions

Reading glass OTHER

Participants from the experimental group have received reading glasses free of cost. Investigators hypothesize that a simple pair of eyeglasses could improve the lives of these people by enabling continued participation in the workforce, restoring productivity levels in both paid and unpaid work, and enhancing the ability to perform everyday tasks. Investigators also hypothesize that reading glasses will improve quality of life.

Reading glass provided

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age (inclusive)
• Presbyopia present (Distance vision \>= 6/12 in both eyes, with inability to see the 6/13 line at 40 cm with both eyes, correctable with near glasses)
• Has never used reading glass or any other eyeglasses
• Selective occupations associated with the need for clear vision at near distances (tailor, barber, self-employed artisan, etc)
• Willing to provide contact information and give informed consent

You may not qualify if:

• Serious medical/mental and or eye condition, and
• Meets criteria but does not wish to participate

Sponsors & Collaborators

• Brac: lead
• VisionSpring: collaborator

Study Sites (1)

BRAC RED

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Narayan Chandra Das

  Brac

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The primary trial outcome was the between-group difference in change in income (self-reported in Bangladeshi taka over the past 4 weeks) between baseline and follow-up surveys. Investigators collecting this information were unaware of participant group assignment.Participant masking with sham glasses was not considered ethical.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: October 25, 2018
• Study Start: April 30, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication.
• Access Criteria: All data will be de-identified.

Locations

BA (1)