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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A | |
Terminated |
NCT00960700 -
A Multi Focal Visual Outcome Study Using Different Near Additions
|
N/A | |
Completed |
NCT00838045 -
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
|
Phase 4 | |
Completed |
NCT00773266 -
Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes
|
N/A | |
Recruiting |
NCT05796453 -
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
|
N/A | |
Completed |
NCT01230060 -
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
|
Phase 3 | |
Completed |
NCT05481125 -
Clareon Toric vs Eyhance Toric
|
N/A | |
Not yet recruiting |
NCT04516889 -
Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
|
N/A | |
Completed |
NCT03733730 -
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
|
N/A | |
Completed |
NCT04098367 -
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
|
N/A | |
Completed |
NCT04528069 -
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
|
N/A | |
Completed |
NCT05852470 -
Evaluation of Clareon Vivity/Vivity Toric
|
N/A | |
Completed |
NCT01061281 -
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
|
Phase 4 | |
Completed |
NCT00625313 -
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
|
N/A | |
Completed |
NCT06389643 -
Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
|
N/A | |
Completed |
NCT03316885 -
Post-Market Clinical Investigation of the Clareon® IOL
|
N/A | |
Completed |
NCT03054649 -
ClarVista HARMONI Toric Trial With Intraoperative Exchange
|
N/A | |
Withdrawn |
NCT04800016 -
Real-World Study of Vivity Intraocular Lenses (IOLs)
|
N/A | |
Recruiting |
NCT06400745 -
Clareon PanOptix Pro vs. Clareon PanOptix - Study A
|
N/A | |
Recruiting |
NCT06401551 -
Clareon PanOptix Pro vs. Clareon PanOptix - Study B
|
N/A |