Cataract Surgery on Advanced Age Related Macular Degeneration Patients

September 27, 2021 updated by: Jeffrey Chambers, University of British Columbia

The Effects of Unilateral and Bilateral Cataract Extraction on Visual Function of Advanced Age-Related Macular Degeneration Patients.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Life style Questionnaire to determine change in visual function.
Time Frame: Through study completion, an average of 1 year

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:

  1. Distance Vision, Mobility, and Lighting (Q: 1-12)
  2. Adjustment (Q:13-16)
  3. Reading and Fine Work (Q: 17-21)
  4. 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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Snellens Chart to determine change in visual acuity
Time Frame: Through study completion, an average of 1 year
Quantitative measure of a patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.
Through study completion, an average of 1 year
Auto Refractive to determine change in visual acuity
Time Frame: Through study completion, an average of 1 year
An auto-refractor is a computerized machine to measure patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H19-00830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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