Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2023-01-03

Brief Summary

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The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.

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Detailed Description

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The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.

This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.

Conditions

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Corneal Astigmatism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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enVista Toric 0.9D intra ocular lens

enVista Toric

Intervention Type DEVICE

enVista Toric IOL

enVista non-Toric (spherical) intra ocular lens

enVista non-Toric (spherical)

Intervention Type DEVICE

enVista non-Toric (spherical) IOL

Interventions

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enVista Toric

enVista Toric IOL

Intervention Type DEVICE

enVista non-Toric (spherical)

enVista non-Toric (spherical) IOL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males and Females subjects age 18 or older on the date of surgery
* Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
* Data available at least 4 weeks after IOL implantation
* Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)

* Study eyes were implanted with the 0.9D toric lens
* Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead

Exclusion Criteria

* History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
* BCDVA of 20/25 or worse for the treated eye(s) after the surgery
* Excessive IOL rotation \> 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No