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NCT05075746 Clinical Trial

Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Corneal Astigmatism Clinical Trial

Official title:
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05075746
Other study ID # BHC-RCR-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 8, 2022
Est. completion date January 3, 2023

Study information
Verified date September 2023
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date January 3, 2023
Est. primary completion date January 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• enVista Toric
enVista Toric IOL
• enVista non-Toric (spherical)
enVista non-Toric (spherical) IOL

Locations
Country Name City State
Canada Bausch Site 01 Calgary Alberta
Canada Bausch Site 03 Langley British Columbia
Canada Bausch Site 02 Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Reduction in Cylindrical Power of the Eye 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
See also
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