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Phase 3 N=122 Treatment

One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Aphakia · Cataract

Bottom Line

View on ClinicalTrials.gov: NCT01230060 ↗
Enrolled (actual)
122
Serious AEs
0.8%
Results posted
Aug 2013
Primary outcome: Primary: Visual Acuity — 108 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
enVista (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Bausch & Lomb Incorporated
Primary completion
Jan 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity		 108 —

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).

Eligibility Criteria

Inclusion Criteria

  • Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
  • Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.
  • Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.

Exclusion Criteria

  • Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
  • Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01230060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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