Clinical trial NCT04045704: Cataract Surgery on Advanced Age Related Macular Degeneration Patients
Official title: The Effects of Unilateral and Bilateral Cataract Extraction on Visual Function of Advanced Age-Related Macular Degeneration Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Macular Degeneration Advanced
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 limited to Epithelial Basement Membrane Dystrophy (EBMD) and retinal detachments.

Primary outcomes:
measure: Life style Questionnaire to determine change in visual function.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Snellens Chart to determine change in visual acuity
timeFrame: Through study completion, an average of 1 year
measure: Auto Refractive to determine change in visual acuity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References: