CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
enVistadevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01230060
NCT01230060Phase 3Completed
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A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Bausch & Lomb Incorporated·interventional·Posted Oct 28, 2010·Updated Aug 22, 2013

In Brief

A Phase 3 clinical trial evaluating enVista for Aphakia and Cataract. Completed, enrolled 122 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAphakia, Cataract
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.7 years ago

Interventions

enVistadevice

One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.