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Cataract Surgery on Advanced Age Related Macular Degeneration Patients

University of British Columbia logo

University of British Columbia

Status

Withdrawn

Conditions

Cataract
Macular Degeneration Advanced

Treatments

Procedure: Cataract Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04045704
H19-00830

Details and patient eligibility

About

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.

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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