Clinical trial NCT05758883: Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
Official title: Post-approval Follow-up Study of the IC-8 Apthera IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 196
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study subjects will be recruited from patients previously enrolled in the IC-8 Apthera intraocular lens (IOL) Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.

Brief summary: The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Detailed description: A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

Eligibility criteria: Inclusion Criteria:

* Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
* Able to comprehend and have signed a statement of informed consent
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Rates of secondary surgical interventions (SSIs)
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Rates of other serious adverse events
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Rates of ocular adverse events
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Rates of subjective visual disturbances
timeFrame: 3 years post IC-8 Apthera IOL implantation
Secondary outcomes:
Other outcomes:
measure: Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA)
timeFrame: 3 years post IC-8 Apthera IOL implantation
measure: Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes in postoperative Manifest Refraction Spherical Equivalent (MRSE) groups
timeFrame: 3 years post IC-8 Apthera IOL implantation
Locations:
city: Tucson
country: United States
facility: Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
state: Arizona
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Omaha
country: United States
facility: Kugler Vision
state: Nebraska
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
city: Ogden
country: United States
facility: Utah Eye Centers
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: