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:
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.
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