Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.
Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.
This study will be conducted in Australia.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B) | Other | Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized |
|
| Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C) | Other | Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Vivity Pro IOL | Device | Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) | Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. | Month 1 postoperative |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iVision Clinic | Recruiting | Campsie | New South Wales | 2194 | Australia | |
| Vision Eye Institute - Chatswood |
Not provided
| Label | URL |
|---|---|
| Educational | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D011305 | Presbyopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
Not provided
Not provided
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
In this contralateral study, subjects will receive Clareon Vivity Pro IOL in one eye and either Clareon Vivity IOL or TECNIS PureSee IOL in the other eye.
Not provided
Not provided
Not provided
|
| Clareon Vivity IOL | Device | Currently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. |
|
| TECNIS PureSee IOL | Device | Currently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject. |
|
| Cataract Surgery | Procedure | Removal of the cloudy lens, followed by implantation of the IOL |
|
| Recruiting |
| Sydney |
| New South Wales |
| 2067 |
| Australia |
| Personaleyes Parramatta | Recruiting | Sydney | New South Wales | 2150 | Australia |
| Wollongong Eye Specialists | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| Focus Vision | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
| Eye Surgery Associates - East Melbourne | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| Peninsula Eye Center | Recruiting | Mornington | Victoria | 3931 | Australia |