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The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enVista Toric 0.9D intra ocular lens |
| ||
| enVista non-Toric (spherical) intra ocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enVista Toric | Device | enVista Toric IOL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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)
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 01 | Calgary | Alberta | T2N 1N4 | Canada | ||
| Bausch Site 03 |
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| ID | Title | Description |
|---|---|---|
| FG000 | enVista Toric 0.9D Intra Ocular Lens | enVista Toric: enVista Toric IOL |
| FG001 | enVista Non-Toric (Spherical) Intra Ocular Lens | enVista non-Toric (spherical): enVista non-Toric (spherical) IOL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | enVista Toric 0.9D Intra Ocular Lens | enVista Toric: enVista Toric IOL |
| BG001 | enVista Non-Toric (Spherical) Intra Ocular Lens | enVista non-Toric (spherical): enVista non-Toric (spherical) IOL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Diopters | 4 weeks after IOL implantation | Eyes | Eyes |
|
4 weeks after IOL implantation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | enVista Toric 0.9D Intra Ocular Lens | enVista Toric: enVista Toric IOL | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior Capsule Opafication | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch & Lomb | 9089271162 | johnson.varughese@bausch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2022 | Sep 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| enVista non-Toric (spherical) |
| Device |
enVista non-Toric (spherical) IOL |
|
| Langley |
| British Columbia |
| V2Y 1N4 |
| Canada |
| Bausch Site 02 | Toronto | Ontario | M2P 2B7 | Canada |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Eyes |
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
| Race (NIH/OMB) | Count of Units | Eyes | Eyes |
|
| Region of Enrollment | Number | Eyes | Eyes |
|
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
|
| 157 |
| 0 |
| 157 |
| 26 |
| 157 |
| EG001 | enVista Non-Toric (Spherical) Intra Ocular Lens | enVista non-Toric (spherical): enVista non-Toric (spherical) IOL | 0 | 145 | 0 | 145 | 9 | 145 |
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