Clinical trial NCT03170154: Clinical Investigation of the Clareon® Intraocular Lens (IOL)
Official title: Clinical Investigation of the Clareon® IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 376
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 objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Detailed description: Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Eligibility criteria: Key Inclusion Criteria:

* Planned routine cataract surgery in at least one eye;
* Calculated lens power within the available range;
* Willing and able to sign an informed consent statement;
* Clear intraocular media other than cataract.

Key Exclusion Criteria:

* Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
* Previous corneal surgery;
* Rubella or traumatic cataract;
* Ocular trauma, previous refractive surgery;
* Current or recent use of certain medications as specified in the protocol;
* Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.

Primary outcomes:
measure: Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative
timeFrame: Month 12 (postoperative)
measure: Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative
timeFrame: Month 12 (postoperative)
measure: Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye
timeFrame: Day 0 (operative), up to Month 12 (postoperative)
Secondary outcomes:
measure: Mean Absolute IOL Rotation
timeFrame: Day 0 (operative), Month 6 (postoperative)
measure: Mean Absolute IOL Misplacement
timeFrame: Day 0 (operative)
measure: Mean Absolute IOL Misalignment
timeFrame: Day 0 (operative), Month 6 (postoperative)
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Alcon Investigative Site
state: California
city: Sacramento
country: United States
facility: Alcon Investigative Site
state: California
city: San Leandro
country: United States
facility: Alcon Investigative Site
state: California
city: Deerfield Beach
country: United States
facility: Alcon Investigative Site
state: Florida
city: Orland Park
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Bloomfield Hills
country: United States
facility: Alcon Investigative Site
state: Michigan
city: Kansas City
country: United States
facility: Alcon Investigative Site
state: Missouri
city: New York
country: United States
facility: Alcon Investigative Site
state: New York
city: Poughkeepsie
country: United States
facility: Alcon Investigative Site
state: New York
city: Elizabeth City
country: United States
facility: Alcon Investigative Site
state: North Carolina
city: Southern Pines
country: United States
facility: Alcon Investigative Site
state: North Carolina
city: Florence
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Ladson
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Austin
country: United States
facility: Alcon Investigative Site
state: Texas
city: Nacogdoches
country: United States
facility: Alcon Investigative Site
state: Texas
city: Appleton
country: United States
facility: Alcon Investigative Site
state: Wisconsin
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: