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.
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.
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.
- Conditions
- Cataract Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Free reading glasses immediately after cataract surgery Receives: Other: Free reading glasses immediately following surgery |
| Control | No intervention | Free 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.
Proportion of patients that reports vision interferes with ability to work
Percentage of total
Measured: Four months after cataract surgery
Secondary outcomes (3)
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
Paid monthly income
Categorical variable
Measured: Four months after cataract surgery
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.
- First posted18 Nov 2023
- Study start17 Mar 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Advanced Center for Eyecare Global
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara OConnor, MD, MPH, Principal investigator, Advanced Center for Eyecare Global
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06136780
- Acronym / sponsor ID
- POWER / POWER Trial
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Advanced Center for Eyecare GlobalUniversity, hospital or other
- Study start
- 17 Mar 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Free reading glasses immediately following surgeryFree reading glasses immediately after cataract surgery |
| Control | No intervention | –Free reading glasses will be given 4 months after cataract surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Previous eye surgery. Ocular comorbidities. Cataract surgery complications resulting in aphakia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free reading glasses immediately following surgeryFree reading glasses will be given immediately after cataract surgery in the intervention arm and four months after cataract surgery in the control arm. | Other | Experimental |
Primary outcome
Proportion of patients that reports vision interferes with ability to work
Time frame: Four months after cataract surgery
Percentage of total
3 secondary outcomes
Number of hours per week engaged in productive activities
Time frame: Four months after cataract surgery
Paid monthly income
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. All data other than personal ID's will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara OConnor, MD, MPH principal investigator
Advanced Center for Eyecare Global
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.