WithdrawnNot Applicable

Cataract Surgery on Advanced Age Related Macular Degeneration Patients

Stopped: No study coordinator available. No patient recruitment possible.

0Started 2019-10

Plain-language summary

The degree at which cataract surgery improves visual function in patients with advanced age-related macular degeneration (Advanced AMD) has been an on-going topic of discussion. Our objective in this study is to determine if patients with Advanced AMD and concurrent cataracts will experience greater improvement in their quality of life from having cataract surgery on one or both eyes. The findings from this project will provide evidence for clinical decision making on whether performing bilateral cataract surgery on Advanced AMD patients is cost-effective and worth the second surgical intervention.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients above the age of fifty with both Advanced AMD and Cataracts bilaterally from the Okanagan Valley will be selected for this study. Patients who chose to have bilateral cataract surgery, were able to understand the research parameters, and had no other severe eye disease that may distort the studies results. Patients will be selected for the study according to the National Eye Institute definition of Advanced AMD. "Advanced AMD (AREDS category 4) is characterized by one or more of the following (in the absence of other causes) in one eye: Geographic atrophy of the RPE involving the foveal center. Neovascular maculopathy that includes the following: * Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane * Serous and/or hemorrhagic detachment of the neurosensory retina or RPE * Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage) * Subretinal and sub-RPE fibrovascular proliferation * Disciform scar (subretinal fibrosis)" Exclusion Criteria: * Severe intraoperative or postoperative complications such as retinal detachments, and capsule ruptures * Inability to complete the required testing (auto-refractive and visual acuity) * Inability to attend appointments * Inability to complete the questionnaire with Co-I assistance * Severe eye disease that may distort the studies results such as but not limi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Life style Questionnaire to determine change in visual function.

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT04045704

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Cataract trials