Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02418871
Other study ID # AIOL-2015-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2015
Est. completion date September 5, 2018

Study information

Verified date May 2021
Source PowerVision
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject. An improved injector system was used.
Procedure:
Cataract surgery
Performed using standard microsurgical techniques

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
PowerVision

Countries where clinical trial is conducted

Hungary,  South Africa, 

Outcome

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
See also
  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