Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

March 22, 2024 updated by: Bausch & Lomb Incorporated
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Bausch Site 01
    • British Columbia
      • Langley, British Columbia, Canada, V2Y 1N4
        • Bausch Site 03
    • Ontario
      • Toronto, Ontario, Canada, M2P 2B7
        • Bausch Site 02

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL in patients with pre-op corneal astigmatism <1.0D. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
enVista Toric 0.9D intra ocular lens
Device: enVista Toric
enVista Toric IOL
enVista non-Toric (spherical) intra ocular lens
Device: enVista non-Toric (spherical)
enVista non-Toric (spherical) IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 weeks after IOL implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Anya Loncaric, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHC-RCR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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