CataractNCT04045704
Cataract Surgery on Advanced Age Related Macular Degeneration Patients
A study testing Cataract Surgery in people with Cataract and Macular Degeneration Advanced, run by University of British Columbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Macular Degeneration Advanced
- What is being tested?
- Cataract Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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)"
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Cataract, Macular Degeneration Advanced
- Being tested
- Cataract Surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract SurgeryProcedure or surgery
Patients with bilateral Advanced Age-related macular degeneration and concurrent cataracts will be receiving bilateral cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: No study coordinator available. No patient recruitment possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Chambers, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045704
- Sponsor's protocol ID
- H19-00830
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Unilateral and Bilateral Cataract Extraction on Visual Function of Advanced Age-Related Macular Degeneration Patients.
- ClinicalTrials.gov ID
- NCT04045704
- Acronym / sponsor ID
- H19-00830
- Conditions
- Cataract, Macular Degeneration Advanced
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No study coordinator available. No patient recruitment possible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract SurgeryPatients with bilateral Advanced Age-related macular degeneration and concurrent cataracts will be receiving bilateral cataract surgery | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Snellens Chart to determine change in visual acuity
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract Surgery in people with Cataract and Macular Degeneration Advanced, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life style Questionnaire to determine change in visual function. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.