Clinical trial NCT03316885: Post-Market Clinical Investigation of the Clareon® IOL
Official title: Post-Market Clinical Investigation of the Clareon® IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Aphakia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 245
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

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 implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).

Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
timeFrame: Year 1 post-implantation from second eye surgery
measure: Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
timeFrame: Year 1 post-implantation from second eye surgery
Secondary outcomes:
measure: Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
timeFrame: Year 2 post-implantation from second eye surgery
measure: Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
timeFrame: Year 2 post-implantation from second eye surgery
measure: Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
timeFrame: Year 3 post-implantation from second eye surgery
measure: Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
timeFrame: Year 3 post-implantation from second eye surgery
measure: Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
timeFrame: Year 1 post-implantation from second eye surgery
measure: UCDVA at 1 Year Post-Implantation - Second Implanted Eye
timeFrame: Year 1 post-implantation from second eye surgery
measure: UCDVA at 2 Years Post-Implantation - First Implanted Eye
timeFrame: Year 2 post-implantation from second eye surgery
measure: UCDVA at 2 Years Post-Implantation - Second Implanted Eye
timeFrame: Year 2 post-implantation from second eye surgery
measure: UCDVA at 3 Years Post-Implantation - First Implanted Eye
timeFrame: Year 3 post-implantation from second eye surgery
measure: UCDVA at 3 Years Post-Implantation - Second Implanted Eye
timeFrame: Year 3 post-implantation from second eye surgery
Other outcomes:
Locations:
city: Footscray
country: Australia
facility: Alcon Investigative Site
state: Victoria
city: Mornington
country: Australia
facility: Alcon Investigative Site
state: Victoria
city: Sydney
country: Australia
facility: Alcon Investigative Site
city: Brest
country: France
facility: Alcon Investigative Site
state: Cedex
city: Lyon
country: France
facility: Alcon Investigative Site
city: Paris
country: France
facility: Alcon Investigative Site
city: Frankfurt
country: Germany
facility: Alcon Investigative Site
city: Heidelberg
country: Germany
facility: Alcon Investigative Site
city: Perugia
country: Italy
facility: Alcon Investigative Site
city: Pisa
country: Italy
facility: Alcon Investigative Site
city: Amsterdam
country: Netherlands
facility: Alcon Investigative Site
city: Jerez De La Frontera
country: Spain
facility: Alcon Investigative Site
state: Cadiz
city: Alcalá De Henares
country: Spain
facility: Alcon Investigative Site
city: Oviedo
country: Spain
facility: Alcon Investigative Site
city: San Sebastián
country: Spain
facility: Alcon Investigative Site
city: Valencia
country: Spain
facility: Alcon Investigative Site
city: Sutton
country: United Kingdom
facility: Alcon Investigative Site
state: Carshalton
city: Brighton
country: United Kingdom
facility: Alcon Investigative Site
city: London
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA, Surgical
role: STUDY_DIRECTOR
References: