Aphakia Clinical Trial
Official title:
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens With an Improved Injector System
Verified date | May 2021 |
Source | PowerVision |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.
Status | Completed |
Enrollment | 53 |
Est. completion date | September 5, 2018 |
Est. primary completion date | March 16, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Key Inclusion Criteria: - Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction; - Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester); - Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism; - Willing and able to comply with schedule for follow-up visits for 36 months after surgery. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes); - Taking systemic medications that may confound the outcome or increase the risk to the subject; - Ocular conditions that may predispose for future complications; - Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject; - Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes; - Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40. - Other protocol-defined exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Hungary | PowerVision Investigative Site | Budapest | |
South Africa | PowerVision Investigative Site | Claremont | Cape Town |
South Africa | PowerVision Investigative Site | Northcliff | Johannesburg |
South Africa | PowerVision Investigative Site | Queenswood | Pretoria |
South Africa | PowerVision Investigative Site | Somerset West |
Lead Sponsor | Collaborator |
---|---|
PowerVision |
Hungary, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accommodative amplitude | Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near. | Month 6 | |
Primary | Best corrected distance visual acuity (BCDVA) | Visual acuity of the eye will be tested with the correction in place. | Month 6 | |
Primary | Rates of adverse events | Adverse events will be collected from time of enrollment to study exit. | Up to Month 36 |
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