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Reading Glass on Livelihoods and Quality of Life in Rural Bangladesh

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ClinicalTrials.gov Identifier: NCT03719196
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
VisionSpring
Information provided by (Responsible Party):
Farzana Sehrin, Brac

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 know as Bangladesh Rural Advancement Committee. Now it is know as BRAC-no full form used) 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 non-paid household activity, 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 1086 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 May 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.


Condition or disease Intervention/treatment Phase
Presbyopia Other: Reading glass Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Reading glass provided

Randomization took place after conducting the census survey. Participants were selected based on the inclusion criteria.

555 random households were surveyed at the baseline. These households have been given reading glasses free of cost.

Other: Reading glass
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.

No Intervention: Non-reading glass
A total of 1086 households were surveyed at the baseline survey. Among them, 555 households have been provided reading glasses. The 531 remaining households were not given reading glasses during the baseline survey. The endline survey will be conducted in May 2018. Upon completing the endline survey, the non-reading glasses group will be provided reading glasses.



Primary Outcome Measures :
  1. Income (Bangladeshi Taka) [ Time Frame: 7 to 8 months. ]
    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 into per hour income before and after the intervention (8 months period) and will be compared between intervention and control group participants to see the difference.


Secondary Outcome Measures :
  1. Secondary outcome 1: Difficulties in performing daily wise task: [ Time Frame: 7 to 8 months. ]
    • Likert scale (scale of 5) will be used to capture data on participants' Difficulties in performing daily wise tasks. Each question related to visual function is rated on a five-pointed scale consisting of (1) None; (2) Mild difficulty; (3) Moderate difficulty; (4) Severe difficulty; (5) Extreme difficulty.

  2. Quality of vision: Likert scale [ Time Frame: 7 to 8 months. ]
    • Self-reported quality of vision as per responses of the respondents will be measured. Measurement will be based on a five point Likert scale as (1) Very Good; (2) Good; (3) Moderate; (4) Bad; (5) Very Bad.

  3. Discomfort in functioning social activities [ Time Frame: 7 to 8 months. ]
    • Social functioning such as feel ashamed or discomfort due to eye problem in the society will be measured. Measurement will be based on a five point Likert scale consisting of (1) Never; (2) rarely; (3) Sometimes; (4) Often; (5) Very often.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 35 years of age
  • Presbyopia positive
  • 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, housewife, etc)
  • Willing to provide contact information and give informed consent

Exclusion Criteria:

  • Less than 35 years of age
  • Presbyopia negative
  • Serious medical/mental and or eye condition, and
  • Meets criteria but does not wish to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719196


Contacts
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Contact: Kamrun Naher +8801761303087 ext 3727 kamrunnaherkemy@gmail.com
Contact: Altamas Pasha +8801716494887 ext 3727 altamas.p@brac.net

Locations
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Bangladesh
BRAC RED Recruiting
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
Brac
VisionSpring
Investigators
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Study Director: Narayan Chandra Das Brac

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Responsible Party: Farzana Sehrin, Senior Research Associate, Brac
ClinicalTrials.gov Identifier: NCT03719196     History of Changes
Other Study ID Numbers: RED_101
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farzana Sehrin, Brac:
Presbyopia
Quality of life
Reading glass
Productivity
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors