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Cataract Surgery on Advanced Age Related Macular Degeneration Patients

Primary Purpose

Cataract, Macular Degeneration Advanced

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Life style Questionnaire to determine change in visual function.
    Our primary outcome will be a life style questionnaire (qualitative) to determine the change in visual function from baseline to after surgery. This questionnaire includes 25 close-ended questions that are graded on a 5 point grading scale from 1 (great difficulty due to vision) and 5 (no problem due to vision). The questions can also be graded as not applicable to an individuals life, or 0 being something there are no longer possible to do, due to vision. The 25 close-ended questions are divided into 4 sub-scales: Distance Vision, Mobility, and Lighting (Q: 1-12) Adjustment (Q:13-16) Reading and Fine Work (Q: 17-21) Activities of Daily Living (Q: 22-25) A total score can range from a 125 indicating best visual function to 0 indicating complete loss of visual function.

    Secondary Outcome Measures

    Snellens Chart to determine change in visual acuity
    Quantitative measure of a patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.
    Auto Refractive to determine change in visual acuity
    An auto-refractor is a computerized machine to measure patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.

    Full Information

    First Posted
    July 17, 2019
    Last Updated
    September 27, 2021
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04045704
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No study coordinator available. No patient recruitment possible.
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Macular Degeneration Advanced

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Cataract Surgery
    Intervention Description
    Patients with bilateral Advanced Age-related macular degeneration and concurrent cataracts will be receiving bilateral cataract surgery
    Primary Outcome Measure Information:
    Title
    Life style Questionnaire to determine change in visual function.
    Description
    Our primary outcome will be a life style questionnaire (qualitative) to determine the change in visual function from baseline to after surgery. This questionnaire includes 25 close-ended questions that are graded on a 5 point grading scale from 1 (great difficulty due to vision) and 5 (no problem due to vision). The questions can also be graded as not applicable to an individuals life, or 0 being something there are no longer possible to do, due to vision. The 25 close-ended questions are divided into 4 sub-scales: Distance Vision, Mobility, and Lighting (Q: 1-12) Adjustment (Q:13-16) Reading and Fine Work (Q: 17-21) Activities of Daily Living (Q: 22-25) A total score can range from a 125 indicating best visual function to 0 indicating complete loss of visual function.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Snellens Chart to determine change in visual acuity
    Description
    Quantitative measure of a patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Auto Refractive to determine change in visual acuity
    Description
    An auto-refractor is a computerized machine to measure patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Cataract Surgery on Advanced Age Related Macular Degeneration Patients

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