- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136780
Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras (POWER)
Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras: The POWER Trial (Post-Operative Work-Related Effect of Reading Glasses)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction The goal of cataract surgery is to improve a patient's vision and by extension, their ability to work and function. Cataract is the clouding of the lens of the eye, and during cataract surgery, the ophthalmologist removes the clouded lens and replaces it with a manufactured lens. Both the natural and the manufactured lens focus light onto the retina, and the length and shape of the eye determine what power intraocular lens to insert at the time of surgery. Using measures taken prior to surgery, cataract surgeons aim to provide patients with clear vision at a distance without glasses. The surgery, when done with the most widely available intraocular lenses by this approach, typically leaves a patient in focus at a distance and dependent on glasses for near work. The assumption with this approach is that the improved vision will enable the patient to return to work and normal functioning. However, in a recent study in Comayagua, Honduras at a facility that exclusively serves low-resource communities (working paper), 75% of patients reported that their vision still interfered with their ability to work four months after cataract surgery. A much smaller number would be expected if cataract surgery alone were able to restore good, functional vision.
A possible explanation for the persistence of vision problems that interfere with work in this cohort is the need for reading glasses. Many occupations involve near work, and having glasses specifically for near work has been shown to increase productivity. Good near vision is also required for a wide variety of tasks around the home and for attending to basic life needs such as dressing and eating. Ideally, following cataract surgery, patients are tested for prescription glasses around one month post-operatively, and glasses prescriptions are written at that time. Postoperative visits and care for cataract patients in the developing world often does not meet this ideal. Returning to the clinic after cataract surgery for postoperative visits can be difficult or impossible, and though they are instructed to return to the clinic to be seen, many patients are lost to follow-up. For the patients who are able to return to be checked, glasses prescriptions are written if they are needed, but such prescriptions are often expensive to fill. Therefore, many patients do not receive any spectacle correction following cataract surgery in the developing world. This is in spite of the fact that the vast majority of these patients at least need glasses for near work.
In a follow-up study to address the effect of reading glasses on work following cataract surgery, 68 patients in the same clinic in Comayagua, Honduras were given free reading glasses at the time of cataract surgery. Three months later, only 22% (n=11) of the 51 patients contacted reported that their vision interfered with their ability to work, and 78%(n=40) reported that the reading glasses that they were given made it easier to work.
Obtaining glasses following surgery might involve significant barriers, including economics (patients are unable to afford the glasses that they need), logistics (patients are unable to travel to a pharmacy that carries glasses) or information (patients lack an understanding of the need for and utility of reading glasses after surgery). Distributing very low-cost reading glasses (~$0.60/pair) at the time of cataract surgery could potentially address these problems. For minimal cost and with few logistical hurdles, giving free reading glasses to postoperative cataract patients ensures that all patients, at a minimum, receive some assistance with near vision. Patients would still be encouraged to follow-up for a custom pair of prescription glasses, as this approach will not address all postoperative need for glasses. However, even if complete follow-up care is inaccessible to a patient for financial or logistical reasons, distribution of free reading glasses at the time of surgery could increase the odds that a person has functional near vision after surgery.
In this study, we want to directly test the effect of providing free reading glasses following cataract surgery on work, income, and functioning through a randomized, controlled trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara E OConnor, MD, MPH
- Phone Number: 970-401-4676
- Email: soconnor@acecaresglobal.org
Study Contact Backup
- Name: Carolyn A Newman
- Phone Number: 954-599-3286
- Email: cnewman@acecaresglobal.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Bilateral cataracts causing VA <6/12 OU, scheduled for cataract surgery at San Benito Jose Clinic in Comayagua Honduras during the week of 3.17.2024 - 3.23.2024.
- Age 50 or older.
Exclusion Criteria:
* Previous eye surgery. Ocular comorbidities. Cataract surgery complications resulting in aphakia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Free reading glasses immediately after cataract 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.
|
No Intervention: Control
Free reading glasses will be given 4 months after cataract surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients that reports vision interferes with ability to work
Time Frame: Four months after cataract surgery
|
Percentage of total
|
Four months after cataract surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hours per week engaged in productive activities
Time Frame: Four months after cataract surgery
|
Productive activities including paid work, unpaid work for self, unpaid work in household
|
Four months after cataract surgery
|
Paid monthly income
Time Frame: Four months after cataract surgery
|
Categorical variable
|
Four months after cataract surgery
|
Visual function score based on National Eye Institute's Visual Function Questionnaire-8.
Time Frame: Four months after cataract surgery
|
Continuous variable generated from validated iinstrument
|
Four months after cataract surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara OConnor, MD, MPH, Advanced Center for Eyecare Global
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POWER Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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