NCT06774183

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,085

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 8, 2025

Last Update Submit

January 13, 2025

Conditions

Keywords

PresbyopiaNear visual impairmentNear vision glassesIncomeKenyaRural

Outcome Measures

Primary Outcomes (3)

  • Repayment behaviour - time

    The proportion of total payments made on time

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

  • Product usage

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

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

  • Repayment behaviour - percentage revenue

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

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

Secondary Outcomes (3)

  • Vision related quality of life

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

  • Income

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

  • Livelihood

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

Study Arms (2)

Near vision glasses

EXPERIMENTAL

Provision of NVGs for presbyopia correction at baseline for study duration

Other: Near vision glasses for presbyopia correction

No glasses

NO INTERVENTION

Participants 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).

Interventions

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

Near vision glasses

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 38568883BACKGROUND
  • 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.

    PMID: 30049615BACKGROUND

MeSH Terms

Conditions

Vision DisordersBlindnessPresbyopia

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive Errors

Study Officials

  • Adam Boxer, MEng

    DOT Glasses

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

February 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01