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Completed

NCT Number: NCT05075746

Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

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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Key information

Conditions

Corneal Astigmatism Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bausch Site 01, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enVista Toric

Device

enVista Toric IOL

enVista non-Toric (spherical)

Device

enVista non-Toric (spherical) IOL

Primary outcomes

  1. Mean Reduction in Cylindrical Power of the Eye

    Time frame: 4 weeks after IOL implantation

    Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2021
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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