Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
1 other identifier
observational
196
1 country
20
Brief Summary
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2023
CompletedFirst Submitted
Initial submission to the registry
February 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2024
CompletedApril 2, 2024
April 1, 2024
1.1 years
February 2, 2023
April 1, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Rates of secondary surgical interventions (SSIs)
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
3 years post IC-8 Apthera IOL implantation
Rates of other serious adverse events
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
3 years post IC-8 Apthera IOL implantation
Rates of ocular adverse events
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
3 years post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances
Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)
3 years post IC-8 Apthera IOL implantation
Other Outcomes (5)
Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes
3 years post IC-8 Apthera IOL implantation
Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes
3 years post IC-8 Apthera IOL implantation
Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)
3 years post IC-8 Apthera IOL implantation
- +2 more other outcomes
Study Arms (1)
IC-8 Apthera intraocular lens (IOL) Group
Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.
Eligibility Criteria
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.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AcuFocus, Inc.lead
Study Sites (20)
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Tucson, Arizona, 85704, United States
Empire Eye & Laser Center
Bakersfield, California, 93309, United States
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Altos Eye Physicians
Los Altos, California, 94024, United States
Advanced Vision Care
Los Angeles, California, 90067, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525, United States
Chu Vision Institute
Bloomington, Minnesota, 55420, United States
Pepose Vision Institute
St Louis, Missouri, 63128, United States
Kugler Vision
Omaha, Nebraska, 68118, United States
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603, United States
Physicians Protocol
Greensboro, North Carolina, 27408, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Parkhurst NuVision
San Antonio, Texas, 78229, United States
Hoopes Vision
Draper, Utah, 84021, United States
Utah Eye Centers
Ogden, Utah, 84403, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2023
First Posted
March 8, 2023
Study Start
January 12, 2023
Primary Completion
February 16, 2024
Study Completion
February 16, 2024
Last Updated
April 2, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share