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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06136780
Other study ID # POWER Trial
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 17, 2024
Est. completion date August 31, 2024

Study information

Verified date November 2023
Source Advanced Center for Eyecare Global
Contact Sara E OConnor, MD, MPH
Phone 970-401-4676
Email soconnor@acecaresglobal.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cataract surgery improves vision and is therefore assumed to improve a person's ability to work and function. Following cataract surgery, most patients do not need glasses to see clearly at distance, but they do require glasses to see clearly up close. If a patient is unable to acquire reading glasses after surgery due to either financial or logistical reasons, their ability to resume work and functioning may be compromised, diminishing the overall benefit to be gained from cataract surgery. Patients in the developing world may be affected disproportionately due to difficulty accessing care postoperatively. In this study, patients receiving cataract surgery at a clinic in Comayagua, Honduras will be randomized to either receive free reading glasses immediately after surgery or four months later. The primary outcome is the proportion of subjects who report that vision interferes with their ability to work. Secondary outcomes will include the number of hours worked each week at productive activities, income level, and visual functioning. The hypotheses are that the patients who receive free reading glasses immediately following surgery will be less likely to report that their vision interferes with their ability to work, they will work at productive activities a greater number of hours each week, their incomes will be higher, and their visual function scores will be higher.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Free reading glasses immediately following surgery
Free reading glasses will be given immediately after cataract surgery in the intervention arm and four months after cataract surgery in the control arm.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Advanced Center for Eyecare Global

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients that reports vision interferes with ability to work Percentage of total Four months after cataract surgery
Secondary Number of hours per week engaged in productive activities Productive activities including paid work, unpaid work for self, unpaid work in household Four months after cataract surgery
Secondary Paid monthly income Categorical variable Four months after cataract surgery
Secondary Visual function score based on National Eye Institute's Visual Function Questionnaire-8. Continuous variable generated from validated iinstrument Four months after cataract surgery
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