Post-Market Clinical Investigation of the Clareon® IOL

Status Completed

Clinical Trial Summary

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Clinical Trial Description

Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03316885
Study type	Interventional
Source	Alcon Research
Contact
Status	Completed
Phase	N/A
Start date	March 14, 2018
Completion date	September 23, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04685538` - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.	Phase 3
Recruiting	`NCT06060041` - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting	`NCT05518539` - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting	`NCT05271942` - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods	N/A
Active, not recruiting	`NCT04778501` - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia	N/A
Completed	`NCT05062564` - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye	N/A
Completed	`NCT03751033` - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings	N/A
Completed	`NCT02529488` - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00	N/A
Completed	`NCT04539548` - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract	Phase 3
Completed	`NCT03740659` - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery	Phase 2
Completed	`NCT03494257` - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification	N/A
Completed	`NCT05119127` - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT03739528` - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery	Phase 3
Completed	`NCT02888210` - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery	Phase 3
Completed	`NCT03356847` - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery	N/A
Completed	`NCT04332640` - Clinical Evaluation of the Next Generation Phaco System	N/A
Recruiting	`NCT03638726` - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification	Phase 4
Completed	`NCT03050697` - Evaluation of the Safety and Performance of the HARMONI® Toric Lens	N/A