Corneal Astigmatism Clinical Trial
Official title:
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
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 |
Verified date | September 2023 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Bausch Site 01 | Calgary | Alberta |
Canada | Bausch Site 03 | Langley | British Columbia |
Canada | Bausch Site 02 | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
Canada,
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 |
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