- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349254
Observational Study of Vision Improvement in Late Stage Dry AMD Patients
February 22, 2021 updated by: Optimal Acuity Corporation
Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device
The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device.
Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity.
Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5R 1A9
- Bochner Eye Institute
-
-
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
Ages Eligible for Study
50 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with vision impairment due to late stage dry age-related macular degeneration.
Description
Inclusion Criteria:
- - Male or female
- - Any race
- - Patient is at least 50 years old
- - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
- - Treated eyes were pseudophakic at the time of treatment.
- - Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (CDVA) of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s).
- - Patient CDVA records are available at baseline and at 12 month post-treatment.
Exclusion Criteria:
- - Corneal disease or disorder in either eye.
- - Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
- Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study.
-
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CDVA
Time Frame: 12 months
|
Best spectacle-corrected distance visual acuity (CDVA)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CNVA
Time Frame: 12 months
|
Best spectacle-corrected near visual acuity (CNVA)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Berry, PhD, Optimal Acuity Corporation
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 (Actual)
August 14, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 14, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Retro1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
Clinical Trials on Dry Age-related Macular Degeneration
-
Luxa Biotechnology, LLCNational Eye Institute (NEI); National Institutes of Health (NIH); Regenerative...RecruitingDry Age-related Macular DegenerationUnited States
-
CHABiotech CO., LtdTerminatedDry Age Related Macular DegenerationKorea, Republic of
-
Smilebiotek Zhuhai LimitedActive, not recruitingDry Age-related Macular DegenerationUnited States
-
Chinese Academy of SciencesBeijing Tongren HospitalUnknownDry Age-related Macular DegenerationChina
-
Apheresis Research InstituteCompletedDry Age Related Macular DegenerationGermany
-
LumiThera, Inc.National Eye Institute (NEI)RecruitingDry Age-related Macular DegenerationUnited States
-
Sucampo Pharma Americas, LLCSucampo Pharmaceuticals, Inc.CompletedDry Age-related Macular DegenerationAustria
-
The New York Eye & Ear InfirmarySuspendedDry Age Related Macular DegenerationUnited States
-
i-Lumen Scientific, Inc.WithdrawnDry Age-related Macular Degeneration
-
Chinese Academy of SciencesThe First Affiliated Hospital of Zhengzhou UniversityUnknownDry Age-related Macular DegenerationChina
Clinical Trials on Corneal treatment by a low vision aid device
-
Optimal Acuity CorporationCompletedAge-related Macular Degeneration | Diabetic Macular EdemaCanada
-
Optimal Acuity CorporationNot yet recruitingDry Age-related Macular Degeneration | Vision Impairment and Blindness
-
Optimal Acuity CorporationBochner Eye InstituteNot yet recruitingAge-related Macular DegenerationCanada
-
Deutsches Herzzentrum MuenchenUnknown
-
Direction Centrale du Service de Santé des ArméesRecruiting
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted