Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Bausch + Lomb

Status: Completed

Conditions: Corneal Astigmatism

Treatments: Device: enVista Toric; Device: enVista non-Toric (spherical)

Study type: Observational

Funder types: Industry

Identifiers

NCT05075746

BHC-RCR-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

302 participants in 2 patient groups

enVista Toric 0.9D intra ocular lens

Treatment:

Device: enVista Toric

enVista non-Toric (spherical) intra ocular lens

Treatment:

Device: enVista non-Toric (spherical)