PresbyopiaNCT03719196
Reading Glass on Livelihoods and Quality of Life in Rural Bangladesh
A study testing Reading glass in people with Presbyopia, run by Brac at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Reading glass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Apr 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35-65 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
Who cannot join
- Serious medical/mental and or eye condition, and
- Meets criteria but does not wish to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh
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.
Read more
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.
Read the detailed description
BRAC (previously known as Bangladesh Rural Advancement Committee) has conducted a study on the Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh in 2017 with financial and technical assistance from VisionSpring. The goal is to assess the impact of reading glasses on economic return and social angles for people in rural areas in Bangladesh.
BRAC and VisionSpring have developed an experimental trial to test the effects of reading glasses. The study will utilize both pre and post-intervention data to identify the causal effects. A randomized control trial is considered to be the most rigorous method of determining whether a causal relationship exists between an intervention and outcome. This is a Randomized Control Trial (RCT) conducted at the household level.
First, investigators selected 59 villages in Bangladesh where the BRAC/VisionSpring distribution of reading glasses has not been present. A census survey was carried out in the 59 villages to identify those suffering from Presbyopia who were eligible for glasses.
Second, participants were recruited through a household Presbyopia screening of individuals over 35 years old and less than 65 years old. Participants with chronic eye diseases that require regular and intensive treatment were excluded from the study.
A structured questionnaire was used at the census survey where demographic information, income, and occupation were asked. Randomization was taken place after the census survey, and a study sample was selected based on the inclusion criteria of the study which are: (1) Over 35 years of age, (2) Presbyopia positive, (3) Have never used reading glass, (4) Selective occupation (tailor, barber, self-employed artisan etc), (5) Willing to provide contact information and give informed consent.
The study proposal defines two rounds of data collection to be conducted; baseline data collection was completed in August 2017 and follow-up data will be conducted in March 2018. A quantitative questionnaire was distributed at the baseline survey in order to understand the livelihoods and quality of life before the intervention began. Skilled interviewers were recruited for this study, and a three-day intensive training was held to reinforce the goals of the study. The training module was developed in Bangla to guide the interviewers in the field. Questions related to socio-demographic characteristics, economic status of the household (e.g. monthly income), the productivity of the respondent and quality of life were collected during baseline, and the same questionnaire will be used in the baseline survey.
A multi-stage simple random sampling technique has been used in this study. The sample size of the study is pre-determined through a power calculation, the inclusion criteria of being a Presbyopic patient. As our primary outcome is income, a non-normally distributed parameter, it is better to compare proportions falling in various quartiles for sample size calculations. With a two-sided significance level of p=0·05 and power of 80%, to detect a 10% between-group difference in the proportion in the highest quartile of income (35% versus 25%), corresponding to an odds ratio of 1.6, 349 participants would be needed in each group. Assuming a 15% rate of attrition based on previous studies in this population, a total sample of 822 persons (411 in each group) would be required.
As the study is randomized at the individual level, there is a possibility to have the spillover effect. To minimize the spillover effect, one participant was selected from each household. There is a risk that members of the control group may see the benefits experienced by others in their community and buy a pair of reading glasses during the study. In an attempt to mitigate this risk, members of the control group were promised free glasses at the end of the study.
Investigators will use a difference-in-difference analysis to estimate the impact of the reading glasses study based on monthly income (primary outcome), and near vision-related quality of life.
To measure the quality of life, investigators will use a standardised instrument to look at respondents' perceptions of their facility with caregiving, household work, ability to (for those who are literate) mobile phone use, personal hygiene, and dependence.
Differences in baseline characteristics by study group will be analysed using the t-test or Wilcoxon rank-sum test for continuous variables with or without normal distribution respectively, the Chi-squared or Fisher's exact test (with cell frequency<5) for binary categorical variables, and ordinal logistic regression for ordinal categorical variables. Normality will be checked using histograms and Q-Q plots.
Data for the primary outcome will be presented as median and inter quartile range due to lack of normality, The change in self-reported monthly income will be categorized by quartiles and the unadjusted and adjusted intervention effects, odds ratio and 95% CI estimated using ordinal logistic regression. Unadjusted and adjusted mean between-group differences will be estimated for the secondary outcomes using linear regression. All variables with P<0.05 in the simple regression analysis will be included in multiple regression models. All statistical analyses will be performed using a commercially available software package (Stata 15.1, StataCorp, College Station TX, USA).
- Conditions
- Presbyopia
- Being tested
- Reading glass
- Keywords
- Presbyopia, Quality of life, Reading glass, Productivity
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading glassOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 to 8 months.
Secondary outcomes (3)
Secondary outcome 1: Difficulties in performing daily wise task:
- 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.
Measured: 7 to 8 months.
Quality of vision: Likert scale
- 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.
Measured: 7 to 8 months.
Discomfort in functioning social activities
- 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.
Measured: 7 to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start30 Apr 2017
- Primary completion30 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brac
- Sponsor type
- University, hospital or other
- Collaborators
- VisionSpring
- Responsible party
- Principal investigator, Farzana Sehrin, Brac
- Investigators
- Narayan Chandra Das, Study director, Brac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719196
- Sponsor's protocol ID
- RED_101
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be de-identified.
Publications
Sehrin F, Jin L, Naher K, Das NC, Chan VF, Li DF, Bergson S, Gudwin E, Clarke M, Stephan T, Congdon N. The effect on income of providing near vision correction to workers in Bangladesh: The THRIVE (Tradespeople and Hand-workers Rural Initiative for a Vision-enhanced Economy) randomized controlled trial. PLoS One. 2024 Apr 3;19(4):e0296115. doi: 10.1371/journal.pone.0296115. eCollection 2024.
PubMed 38568883
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh
- ClinicalTrials.gov ID
- NCT03719196
- Acronym / sponsor ID
- RED_101
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Quality of life, Reading glass, Productivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- BracUniversity, hospital or other
- Collaborators
- VisionSpring
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BRAC (previously known as Bangladesh Rural Advancement Committee) has conducted a study on the Assessment of the Impact of Reading Glasses on Livelihoods and Quality of Life in the Context of Rural Bangladesh in 2017 with financial and technical assistance from VisionSpring. The goal is to assess the impact of reading glasses on economic return and social angles for people in rural areas in Bangladesh.
BRAC and VisionSpring have developed an experimental trial to test the effects of reading glasses. The study will utilize both pre and post-intervention data to identify the causal effects. A randomized control trial is considered to be the most rigorous method of determining whether a causal relationship exists between an intervention and outcome. This is a Randomized Control Trial (RCT) conducted at the household level.
First, investigators selected 59 villages in Bangladesh where the BRAC/VisionSpring distribution of reading glasses has not been present. A census survey was carried out in the 59 villages to identify those suffering from Presbyopia who were eligible for glasses.
Second, participants were recruited through a household Presbyopia screening of individuals over 35 years old and less than 65 years old. Participants with chronic eye diseases that require regular and intensive treatment were excluded from the study.
A structured questionnaire was used at the census survey where demographic information, income, and occupation were asked. Randomization was taken place after the census survey, and a study sample was selected based on the inclusion criteria of the study which are: (1) Over 35 years of age, (2) Presbyopia positive, (3) Have never used reading glass, (4) Selective occupation (tailor, barber, self-employed artisan etc), (5) Willing to provide contact information and give informed consent.
The study proposal defines two rounds of data collection to be conducted; baseline data collection was completed in August 2017 and follow-up data will be conducted in March 2018. A quantitative questionnaire was distributed at the baseline survey in order to understand the livelihoods and quality of life before the intervention began. Skilled interviewers were recruited for this study, and a three-day intensive training was held to reinforce the goals of the study. The training module was developed in Bangla to guide the interviewers in the field. Questions related to socio-demographic characteristics, economic status of the household (e.g. monthly income), the productivity of the respondent and quality of life were collected during baseline, and the same questionnaire will be used in the baseline survey.
A multi-stage simple random sampling technique has been used in this study. The sample size of the study is pre-determined through a power calculation, the inclusion criteria of being a Presbyopic patient. As our primary outcome is income, a non-normally distributed parameter, it is better to compare proportions falling in various quartiles for sample size calculations. With a two-sided significance level of p=0·05 and power of 80%, to detect a 10% between-group difference in the proportion in the highest quartile of income (35% versus 25%), corresponding to an odds ratio of 1.6, 349 participants would be needed in each group. Assuming a 15% rate of attrition based on previous studies in this population, a total sample of 822 persons (411 in each group) would be required.
As the study is randomized at the individual level, there is a possibility to have the spillover effect. To minimize the spillover effect, one participant was selected from each household. There is a risk that members of the control group may see the benefits experienced by others in their community and buy a pair of reading glasses during the study. In an attempt to mitigate this risk, members of the control group were promised free glasses at the end of the study.
Investigators will use a difference-in-difference analysis to estimate the impact of the reading glasses study based on monthly income (primary outcome), and near vision-related quality of life.
To measure the quality of life, investigators will use a standardised instrument to look at respondents' perceptions of their facility with caregiving, household work, ability to (for those who are literate) mobile phone use, personal hygiene, and dependence.
Differences in baseline characteristics by study group will be analysed using the t-test or Wilcoxon rank-sum test for continuous variables with or without normal distribution respectively, the Chi-squared or Fisher's exact test (with cell frequency<5) for binary categorical variables, and ordinal logistic regression for ordinal categorical variables. Normality will be checked using histograms and Q-Q plots.
Data for the primary outcome will be presented as median and inter quartile range due to lack of normality, The change in self-reported monthly income will be categorized by quartiles and the unadjusted and adjusted intervention effects, odds ratio and 95% CI estimated using ordinal logistic regression. Unadjusted and adjusted mean between-group differences will be estimated for the secondary outcomes using linear regression. All variables with P<0.05 in the simple regression analysis will be included in multiple regression models. All statistical analyses will be performed using a commercially available software package (Stata 15.1, StataCorp, College Station TX, USA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reading glass provided | Experimental | Other: Reading glassRandomization 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. |
| 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 35-65 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
Key exclusion criteria (2 listed)
- Serious medical/mental and or eye condition, and
- Meets criteria but does not wish to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading glassParticipants 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. | Other | Reading glass provided |
Primary outcome
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 before and after the intervention (8 months period) and will be compared between intervention and control group participants to see the difference.
3 secondary outcomes
Secondary outcome 1: Difficulties in performing daily wise task:
Time frame: 7 to 8 months.
Quality of vision: Likert scale
Time frame: 7 to 8 months.
Discomfort in functioning social activities
Time frame: 7 to 8 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 38568883Sehrin F, Jin L, Naher K, Das NC, Chan VF, Li DF, Bergson S, Gudwin E, Clarke M, Stephan T, Congdon N. The effect on income of providing near vision correction to workers in Bangladesh: The THRIVE (Tradespeople and Hand-workers Rural Initiative for a Vision-enhanced Economy) randomized controlled trial. PLoS One. 2024 Apr 3;19(4):e0296115. doi: 10.1371/journal.pone.0296115. eCollection 2024.
- Individual participant dataSharing planned: Yes. All data will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narayan Chandra Das study director
Brac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading glass in people with Presbyopia, run by Brac at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Income (Bangladeshi Taka) (time frame: 7 to 8 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.