Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05075746
• Collaborator: (none)
• Enrollment: 384
• Locations: 3
• Anticipated Duration (Months): 3.8
• Patients Per Site: 128
• Patients Per Site Per Month: 33.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Astigmatism	Device: enVista Toric; Device: enVista non-Toric (spherical)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 384 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
• Actual Study Start Date: Mar 8, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch Site 01	Calgary	Alberta	Canada	T2N 1N4
2	Bausch Site 03	Langley	British Columbia	Canada	V2Y 1N4
3	Bausch Site 02	Toronto	Ontario	Canada	M2P 2B7

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Anya Loncaric, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT05075746
• Other Study ID Numbers: BHC-RCR-001
• First Posted: Oct 13, 2021
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Mar 18, 2022