Status:
COMPLETED
Post-Market Clinical Investigation of the Clareon® IOL
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Aphakia
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and perform...
Detailed Description
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be i...
Eligibility Criteria
Inclusion
- Key
- Diagnosed with bilateral cataracts
- Planned small incision cataract removal surgery
- Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits
- Key
Exclusion
- Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
- Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
- Pregnant or lactating, current or planned during the course of the study
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT03316885
Start Date
March 14 2018
End Date
September 23 2021
Last Update
August 21 2023
Active Locations (19)
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1
Alcon Investigative Site
Footscray, Victoria, Australia, 3011
2
Alcon Investigative Site
Mornington, Victoria, Australia, 3931
3
Alcon Investigative Site
Sydney, Australia, 2067
4
Alcon Investigative Site
Brest, Cedex, France, 29609