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Presbyopia CorrectionNCT06774183

Effect of Presbyopia Correction on Livelihood and Repayment Among Solar Customers in Western Region, Kenya

A study testing Near vision glasses for presbyopia correction in people with Presbyopia Correction and Visual Impairment and Blindness (Excl Colour Blindness), run by Dot Glasses Kenya.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

With age, people lose the ability to see things that are near them clearly. This is known as presbyopia. Although this is a normal ageing process, it can be corrected with near vision eyeglasses - colloquially known as reading glasses - and people should not have to "put up with" poor near vision. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Near vision glasses for presbyopia correction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,085 participants
Where
No sites listed yet
Study dates
Feb 2025to Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40 years or older
  • NVI secondary to presbyopia: presenting NVA <N6 at 40cm, correctable with NVGs to N6 or better at 40cm.
  • Purchased their product >=3 months ago with >= 6 months of repayments remaining on their PAYG contract.
  • The product is in the entry level category, priced between KES 7,000 and 30,000 (USD 46 and 196 at prevailing exchange rates during writing).
  • Do not currently own a pair of NVGs.
  • Living in a target counties of Busia, Siaya, Vihiga or Kakamega.

Who cannot join

  • Age under 40 years.
  • Distance Visual Acuity of worse than 20/40.
  • Already own NVGs.
  • Presenting NVA N6 or better at 40 centimetres.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Effect of Presbyopia Correction on Livelihood and Repayment Among Solar Customers in Western Region, Kenya: Evaluating the Impact of Providing Near Vision Correction to Solar Customers

With age, people lose the ability to see things that are near them clearly. This is known as presbyopia. Although this is a normal ageing process, it can be corrected with near vision eyeglasses - colloquially known as reading glasses - and people should not have to "put up with" poor near vision. By improving the ability to see things that are up-close, near vision eyeglasses allow people to perform tasks with greater ease. This improves their quality of life, and increases their productivity and income. DOT Glasses provides people in East Africa with a range of eyeglasses, including those to improve near vision.

In addition, products sold to communities through loans repaid at regular intervals (known as asset financing), allow people in underserved communities to harness electricity through solar products and to own electronic devices, such as mobile phones. This also improves their quality of life, and increases their productivity and income. Sun King is one of the leading providers of solar products through loans in Kenya.

This study will gather evidence and insights from existing Sun King customers with poor near vision in Busia, Siaya, Vihiga and Kakamega. The investigators will explore how much giving people glasses to improve their near vision impacts their ability to make repayments, their incomes and livelihoods, and their overall quality of life. It will also be studied how the glasses affect participants usage of the solar device or mobile phone.

Read the detailed description

Aim:

To identify the impact on SHS and mobile phone use, repayment behaviour and income, of providing near vision glasses (NVGs) to customers with near vision impairment (NVI).

Primary objective:

● To determine the effect of presbyopia correction via NVGs, on SHS and mobile phone repayment behaviour:

  • The proportion of total payments made on time
  • Percentage of expected revenue collected within a six month time period

Secondary objectives:

  • To determine the proportion of time SHS and mobile phones products are enabled among NVGs users
  • To assess the effect of NVGs on quality of life among Solar Home System users.
  • To measure the effect of NVGs on livelihood and income among Solar Home System users.
  • To determine the value that Solar Home System users attached to the solar lighting and daily/weekly time using it.

POPULATION Sun King SHS or mobile phone (purchased on credit) users, aged 40 years or above, with presbyopia, who purchased their product at least 3 months ago and have at least 6 months of repayments remaining.

INTERVENTION Provision of NVGs for presbyopia correction.

CONTROL Delayed provision of NVGs, presbyopia correction.

TIME FRAME 6 months

HYPOTHESIS Correcting presbyopia with NVGs improves the rate of SHS or mobile phone repayments made on time.

NULL HYPOTHESIS Correcting presbyopia with NVGs does not change the rate of repayments made or the proportion of time the participants have their system enabled.

STUDY DESIGN Randomised Control Trial.

STUDY AREA The study area includes rural, peri-urban and urban communities in Busia, Siaya, Vihiga and Kakamega in Western Kenya

SAMPLE SIZE DETERMINATION Mean solar product repayments to Sun King for the entry level category, products priced between KES 7,000 and 30,000, are KES 405 per month. To be able to identify a 10% difference in repayments between the groups, with a two-sided significance level of p=0.05 and power of 90%, a sample size of 461 per group is required. The investigators will screen 1,480 people, of which it is expected 1085 to meet the enrolment criteria. 543 will be randomly allocated to join the experimental group who will be provided their glasses at the start of the study and 543 will be randomly allocated to join the control group who will receive their glasses at the end of the study. The investigators expect the attrition rate to be similar across both groups, at ~15%. This will give us a final sample per group of at least 461.

SAMPLING PROCEDURES A software application will be used to randomly select whether participants go into the study or control group. The application will randomly select from the participants list, then randomly invite participants on one of two days per locality for the screening, provision of NVGs and baseline surveys. The day attended will determine participants' allocation to the glasses or control groups.

All participants on day two will receive glasses and all on day one do not (control). Neither group will be informed beforehand if they are receiving glasses or not; they will only be invited for a screening.

  • Glasses will not be dispensed on the first day at each location and then will be dispensed on the second day.
  • When contacted, all participants will be invited for screening and told that they will receive eyeglasses at a date to be confirmed.

RECRUITMENT OF STUDY SUBJECTS

Sun King will call existing customers with the following criteria to invite them to participate in the study:

  1. Aged over 40 years.
  2. Purchased their product >=3 months ago and have >=6 months of repayments remaining on their PAYG contract.
  3. The product is in the entry level category, priced between KES 7,000 and 30,000 (USD 46 and 196 at current exchange rates).
  4. Reside in the counties of focus.

If they are willing to participate they will be asked if they have a pair of NVGs. If they do not have a pair, they will then be added to the initial participant list. If they have a pair, they will be excluded from selection. The selected study participants will be asked to complete and sign a consent form prior to the initial assessment and then randomly allocated to the experimental or control group.

Participants will receive compensation for travel expenses of 300 KSH

Data collection methodology

The data collection will be primarily quantitative. The data will be collected through:

  1. Sun King's customer relationship management system, which records each client's product details, repayment schedule, payment details and the duration of the product's activation. This will be shared for analysis in a spreadsheet.
  2. Individual surveys, using a semi-structured questionnaire. The surveys will be conducted in-person using Kobo Toolbox on mobile devices.
  3. NVA test.

RESEARCH STAFF TRAINING

  1. For the study the study team will be working with GMaurich Insights, a social research agency whose data scientists have over 20 years of combined experience.
  2. GMaurich will provide Research Assistants (RAs) for the study.
  3. DOT Glasses take the RAs through a 1-day training. The curriculum will cover:
  4. Research ethics and informed consent.
  5. Introduction to eye health and visual acuity.
  6. How to screen using the NVA chart.
  7. How to assess, at a basic level, if there may be more complicated eye conditions, and the referral process for other eye issues. It will be made clear to participants that this vision screening does not constitute a thorough ophthalmic examination, and that they should seek assessment for other visual/ocular symptoms elsewhere.
  8. How to distribute the glasses.
  9. Explaining to participants how to use the glasses and which tasks they should/should not be used for.
  10. Going through the question set.
  11. GMaurich RAs will then need to pass a DOT Glasses practical assessment to be able to distribute the glasses.

DATA COLLECTION

  1. A sample of 20 surveys will be completed to pilot the tool and stress-test the process.
  2. Participants will be invited to a convenient location for the data collection. Depending on the day, the participants will be assigned to either the study or control group.
  3. Data collection procedure in the field:
  4. The RAs will explain the study purpose and process to the participant, and obtain written, informed consent before proceeding.
  5. Conduct a DVA test with participants needing to achieve a minimum of 20/40.
  6. Conduct a NVA test using Precision Vision Near Vision Chart:
  7. Test presenting Near Visual Acuity. ii. Assess required near correction lens power (dioptres). iii. Retest corrected NVA. iv. Refer to a specialist if:
  8. The participant has NVA worse than N6 at 40 centimetres and is not correctable by any of the available lenses.
  9. The participant has other visible ocular pathology. d. Conduct the survey. e. For the study group: i. Provide the correct power and fit the glasses. ii. If no NVGs are required, offer sunglasses for their time and participation. f. For the control group: i. Assess the correct power, but delay glasses provision. ii. The eyeglasses will be provided at the end line.
  10. Follow up period:
  11. Intervention group: i. At 3 months participants will have an over the phone follow up to ask whether or not they are using the glasses. ii. At 6 months follow up questionnaire and eye screening in person. b. Control group: i. At 6 months followed up questionnaire, eye screening and distribution of glasses.

COLLECTED DATA An overview of key question areas in the study tools is outlined below. Participant demographics

  • Age
  • Gender
  • Location
  • Education level
  • Marital status
  • Household size

Credit Questions

  • Type of Pay-As-You-Go device they have?
  • How and who pays for the device?
  • Priority of paying for the device?

Solar questions

  • Usage of product?
  • Reasons for not paying?
  • Vision challenges with the solar product?

Income and livelihoods

  • Income sources and monthly income
  • Income adequacy questions (perceived)

Vision-related quality of life assessment

● focusing on how their poor near vision has affected their daily lives.

At the end line, participants will be asked questions that measure their use of NVGs and the impact they have made on the above categories. With the control group getting a similar questions set.

Being tested
Near vision glasses for presbyopia correction
Keywords
Presbyopia, Near visual impairment, Near vision glasses, Income, Kenya, Rural
Medical subject headings
Vision Disorders, Blindness, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near vision glasses for presbyopia correctionOther

    Provision of near vision glasses for presbyopia correction to individuals who did not previously have glasses and have correctable presbyopia

Study groups in NCT06774183
Study groupRoleWhat they receive
Near vision glassesExperimentalProvision of NVGs for presbyopia correction at baseline for study duration
Receives: Other: Near vision glasses for presbyopia correction
No glassesNo interventionParticipants in the no intervention control group will be followed over the same period as the near vision glasses intervention group but will have no near vision glasses provided (glasses will be provided at the end of the study).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Repayment behaviour - time

    The proportion of total payments made on time

    Measured: Measured at baseline and end of the study (6 months)

  2. Product usage

    The proportion of time solar home systems and mobile phones products are enabled

    Measured: Measured at baseline and end of the study (6 months)

  3. Repayment behaviour - percentage revenue

    Percentage of expected revenue collected by the solar home system provider within a six month time period

    Measured: Measured at baseline and end of the study (6 months)

Secondary outcomes (3)
  1. Vision related quality of life

    Changes in perceived vision related quality of life assessed by questionnaire.

    Vision related quality of life will be assessed by 9 questions relating to how much difficulty the participant has in performing day to day tasks relating to their eyesight. Questions are answered on a scale from no difficulty at all to having to unable to perform the task due to eyesight issues.

    Measured: Measured at baseline and end of the study (6 months)

  2. Income

    Changes in self-reported income assessed by questionnaire.

    Participants will be asked how they generate an income and for each income source they will be asked how much they make per month from the income source (in KES).

    Measured: Measured at baseline and end of the study (6 months)

  3. Livelihood

    Changes in livelihood (source of income) assessed by questionnaire.

    Participants will be asked what there source of income is with the option to select multiple sources of income.

    Measured: Measured at baseline and end of the study (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
None (open label)
Enrolment
1,085 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06774183
Sponsor's protocol ID
P1751-2024
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymised IPD data may be shared with other researchers for future research.

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
  • Reddy PA, Congdon N, MacKenzie G, Gogate P, Wen Q, Jan C, Clarke M, Kassalow J, Gudwin E, O'Neill C, Jin L, Tang J, Bassett K, Cherwek DH, Ali R. Effect of providing near glasses on productivity among rural Indian tea workers with presbyopia (PROSPER): a randomised trial. Lancet Glob Health. 2018 Sep;6(9):e1019-e1027. doi: 10.1016/S2214-109X(18)30329-2. Epub 2018 Jul 23.

    PubMed 30049615

Questions about this trial

What is this clinical trial studying?

A study testing Near vision glasses for presbyopia correction in people with Presbyopia Correction and Visual Impairment and Blindness (Excl Colour Blindness), run by Dot Glasses Kenya.

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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adam Boxer, MEng (732 587 508 ext. +254, adam.boxer@dotglasses.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repayment behaviour - time (time frame: Measured at baseline and end of the study (6 months)). The study lists 3 primary outcomes in all. 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 NCT06774183, which also lists 2 linked publications.

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 14 Jan 2025.

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