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

NCT06136780 | Unknown

• 1 other identifier: POWER Trial
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that reports vision interferes with ability to work

  Percentage of total

  Four months after cataract surgery

Secondary Outcomes (3)

• Number of hours per week engaged in productive activities

  Four months after cataract surgery

• Paid monthly income

  Four months after cataract surgery

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

  Four months after cataract surgery

Study Arms (2)

Experimental

EXPERIMENTAL

Free reading glasses immediately after cataract surgery

Other: Free reading glasses immediately following surgery

Control

NO INTERVENTION

Free reading glasses will be given 4 months after cataract surgery

Interventions

Free reading glasses immediately following surgery OTHER

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

Experimental

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Advanced Center for Eyecare Global: lead

Study Officials

• Sara OConnor, MD, MPH

  Advanced Center for Eyecare Global

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara E OConnor, MD, MPH

CONTACT

970-401-4676; soconnor@acecaresglobal.org

Carolyn A Newman

CONTACT

954-599-3286; cnewman@acecaresglobal.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 17, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR