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Cataract SurgeryPOWERNCT06136780

Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras

A study testing Free reading glasses immediately following surgery in people with Cataract Surgery, run by Advanced Center for Eyecare Global.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cataract Surgery
What is being tested?
Free reading glasses immediately following surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
17 Mar 2024to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Previous eye surgery. Ocular comorbidities. Cataract surgery complications resulting in aphakia.

Trial locations and contacts

No sites are listed yet.

Sara E OConnor, MD, MPH contact

970-401-4676

soconnor@acecaresglobal.org

About this study

Official title: 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)

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.

Read the 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.

Being tested
Free reading glasses immediately following surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free reading glasses immediately following surgeryOther

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

Study groups in NCT06136780
Study groupRoleWhat they receive
ExperimentalExperimentalFree reading glasses immediately after cataract surgery
Receives: Other: Free reading glasses immediately following surgery
ControlNo interventionFree reading glasses will be given 4 months after cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients that reports vision interferes with ability to work

    Percentage of total

    Measured: Four months after cataract surgery

Secondary outcomes (3)
  1. Number of hours per week engaged in productive activities

    Productive activities including paid work, unpaid work for self, unpaid work in household

    Measured: Four months after cataract surgery

  2. Paid monthly income

    Categorical variable

    Measured: Four months after cataract surgery

  3. Visual function score based on National Eye Institute's Visual Function Questionnaire-8.

    Continuous variable generated from validated iinstrument

    Measured: Four months after cataract surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start17 Mar 2024 (estimated)
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136780
Sponsor's protocol ID
POWER Trial
Acronym
POWER
Status last verified
Nov 2023
First submitted
13 Nov 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data other than personal ID's will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Free reading glasses immediately following surgery in people with Cataract Surgery, run by Advanced Center for Eyecare Global.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara E OConnor, MD, MPH (970-401-4676, soconnor@acecaresglobal.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients that reports vision interferes with ability to work (time frame: Four months after cataract surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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