Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Completed

• Conditions: Corneal Astigmatism
• Interventions: Device: enVista non-Toric (spherical); Device: enVista Toric

• Registration Number: NCT05075746
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-13
• Study Start: 2022-03-08
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2023-09
• Results First Submitted: 2023-09-15
• Results First Submitted QC: 2023-09-15
• Results First Posted: 2024-03-21
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
enVista non-Toric (spherical) intra ocular lens	enVista non-Toric (spherical)	-
enVista Toric 0.9D intra ocular lens	enVista Toric	-

Primary Outcome Measures

Name	Time	Method
Mean Reduction in Cylindrical Power of the Eye	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).

Trial Locations

Locations (3)

Bausch Site 03; 🇨🇦 Langley, British Columbia, Canada

Bausch Site 02; 🇨🇦 Toronto, Ontario, Canada

Bausch Site 01; 🇨🇦 Calgary, Alberta, Canada