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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000770763

Enrollment

Registered

2013-07-10

Start date

2013-07-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 len

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results