Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
1 other identifier
observational
302
1 country
3
Brief Summary
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedStudy Start
First participant enrolled
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedResults Posted
Study results publicly available
March 21, 2024
CompletedMarch 27, 2024
September 1, 2023
10 months
September 30, 2021
September 15, 2023
March 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
enVista Toric 0.9D intra ocular lens
enVista non-Toric (spherical) intra ocular lens
Interventions
enVista non-Toric (spherical) IOL
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Bausch Site 01
Calgary, Alberta, T2N 1N4, Canada
Bausch Site 03
Langley, British Columbia, V2Y 1N4, Canada
Bausch Site 02
Toronto, Ontario, M2P 2B7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johnson Varughese
- Organization
- Bausch & Lomb
Study Officials
- STUDY DIRECTOR
Anya Loncaric
Bausch Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 13, 2021
Study Start
March 8, 2022
Primary Completion
January 3, 2023
Study Completion
January 3, 2023
Last Updated
March 27, 2024
Results First Posted
March 21, 2024
Record last verified: 2023-09