WithdrawnPhase 4ACTRN12613000770763

A Multi-Center, Open-Label, Post-market, Investigation of Clinical Outcomes in Eyes implanted with enVista Registered Trademark Toric Intraocular Lens

A Multi-Center, Open-Label, Post-market, Investigation of Clinical Outcomes in patients implanted with Bausch + Lomb enVista Registered Trademark Toric Intraocular Lens (IOL) in one or both eyes as part of standard cataract surgery for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction.

Sponsor

Bausch + Lomb Incorporated

Enrollment

20 participants

Start Date

Jul 29, 2013

Study Type

Interventional

Conditions

High corneal astigmatism Cataract

Summary

The primary objective of this investigation is to collect and evaluate clinical outcomes in patients implanted with Bausch + Lomb enVista Toric Intraocular Lens (IOL) in one or two eyes as part of standard cataract surgery for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Subjects must have a best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 (or equivalent) after toric IOL implantation, have a target postoperative manifest refraction spherical equivalent (MRSE) projected to be within +/-0.37D and postoperative residual astigmatism of less than or equal to 0.50D as reflected by the Toric calculator

Exclusion Criteria1

Subjects with ocular comorbidities (eg, diabetic retinopathy, macular degeneration, chronic inflammations, corneal opacities, dystrophies, or diseases, amblyopia etc) which could be expected to reduce potential Best corrected Distance Visual Acuity (BCDVA) to 20/32 or worse during study participation, irregular astigmatism and history of corneal (including refractive) or intraocular surgery in the enrolled eye

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Interventions

Each study participant will be observed for a duration of 3 months after intervention commencement in this study, for the reduction of the effects of preoperative corneal astigmatism on postoperative

Each study participant will be observed for a duration of 3 months after intervention commencement in this study, for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction after cataract surgery with implantation of enVista Toric Intraocular Lens (IOL) in one or both eyes. The enVista Toric Intraocular Lens is a single piece posterior chamber intraocular lens developed to replace the human crystalline lens in adult patients in whom the cataractous human lens has been removed during cataract surgery. The duration of the full cataract surgery is approximately 30 minutes of which the implantation procedure of enVista Intraocular lens is approximately 5 minutes.