Corneal Astigmatism
Conditions
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.
Interventions
DEVICEenVista Toric
enVista Toric IOL
DEVICEenVista non-Toric (spherical)
enVista non-Toric (spherical) IOL
Sponsors
Bausch & Lomb Incorporated
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| enVista Toric 0.9D Intra Ocular Lens enVista Toric: enVista Toric IOL | 157 |
| enVista Toric 0.9D Intra Ocular Lens enVista Toric: enVista Toric IOL | 192 |
| enVista Non-Toric (Spherical) Intra Ocular Lens enVista non-Toric (spherical): enVista non-Toric (spherical) IOL | 145 |
| enVista Non-Toric (Spherical) Intra Ocular Lens enVista non-Toric (spherical): enVista non-Toric (spherical) IOL | 191 |
| Total | 685 |
Baseline characteristics
| Characteristic | enVista Toric 0.9D Intra Ocular Lens | Total | enVista Non-Toric (Spherical) Intra Ocular Lens |
|---|---|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 8.73 | 71.6 years STANDARD_DEVIATION 8.63 | 72.5 years STANDARD_DEVIATION 8.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Asian | 24 Eyes | 49 Eyes | 25 Eyes |
| Race (NIH/OMB) Black or African American | 5 Eyes | 9 Eyes | 4 Eyes |
| Race (NIH/OMB) More than one race | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Unknown or Not Reported | 64 Eyes | 130 Eyes | 66 Eyes |
| Race (NIH/OMB) White | 99 Eyes | 195 Eyes | 96 Eyes |
| Region of Enrollment Canada | 192 Eyes | 383 Eyes | 191 Eyes |
| Sex: Female, Male Female | 112 Eyes | 208 Eyes | 96 Eyes |
| Sex: Female, Male Male | 80 Eyes | 175 Eyes | 95 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 145 |
| other Total, other adverse events | 26 / 157 | 9 / 145 |
| serious Total, serious adverse events | 0 / 157 | 0 / 145 |
Outcome results
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).
Time frame: 4 weeks after IOL implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| enVista Toric 0.9D Intra Ocular Lens | Mean Reduction in Cylindrical Power of the Eye | 0.432 Diopters | Standard Deviation 0.4468 |
| enVista Non-Toric (Spherical) Intra Ocular Lens | Mean Reduction in Cylindrical Power of the Eye | 0.071 Diopters | Standard Deviation 0.4073 |