Near vision glasses for presbyopia correction
OtherProvision of near vision glasses for presbyopia correction to individuals who did not previously have glasses and have correctable presbyopia
NCT Number: NCT06774183
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 opening soon.
Get Notified40 year and older
All sexes
Interventional
Not applicable
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:
Secondary objectives:
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.
RECRUITMENT OF STUDY SUBJECTS
Sun King will call existing customers with the following criteria to invite them to participate in the study:
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:
RESEARCH STAFF TRAINING
DATA COLLECTION
i. Test presenting Near Visual Acuity. ii. Assess required near correction lens power (dioptres). iii. Retest corrected NVA. iv. Refer to a specialist if:
a. 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
Credit Questions
Solar questions
Income and livelihoods
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provision of near vision glasses for presbyopia correction to individuals who did not previously have glasses and have correctable presbyopia
Time frame: Measured at baseline and end of the study (6 months)
The proportion of total payments made on time
Time frame: Measured at baseline and end of the study (6 months)
The proportion of time solar home systems and mobile phones products are enabled
Time frame: Measured at baseline and end of the study (6 months)
Percentage of expected revenue collected by the solar home system provider within a six month time period
Time frame: Measured at baseline and end of the study (6 months)
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.
Time frame: Measured at baseline and end of the study (6 months)
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).
Time frame: Measured at baseline and end of the study (6 months)
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.
Contact information is provided by the study sponsor or research team.
Dot Glasses Kenya
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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