Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

Post-approval Follow-up Study of the IC-8 Apthera IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05758883
• Other study ID #: SAIL-101-PAS
• Status: Completed
• Start date: January 12, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2024
• Source: AcuFocus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Locations

Country	Name	City	State
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Hoopes Vision	Draper	Utah
United States	Eye Center of Northern Colorado	Fort Collins	Colorado
United States	Physicians Protocol	Greensboro	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Harvard Eye Associates	Laguna Hills	California
United States	Altos Eye Physicians	Los Altos	California
United States	Advanced Vision Care	Los Angeles	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Utah Eye Centers	Ogden	Utah
United States	Kugler Vision	Omaha	Nebraska
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Alterman, Modi & Wolter	Poughkeepsie	New York
United States	Pepose Vision Institute	Saint Louis	Missouri
United States	Parkhurst NuVision	San Antonio	Texas
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center	Tucson	Arizona
United States	Bucci Laser Vision	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monocular best-corrected distance visual acuity (BCDVA) in IC-8 Apthera eyes and fellow eyes	Monocular best-corrected distance visual acuity will be assessed at the Study visit in the IC-8 Apthera intraocular lens (IOL) eyes and in the fellow eyes	3 years post IC-8 Apthera IOL implantation
Other	Rate of intraocular lens (IOL) removals due to visual/optical reasons in the IC-8 Apthera eyes and fellow eyes	Rate of intraocular lens (IOL) removals (based on eyes with events) will be assessed at the Study visit in the IC-8 Apthera IOL eyes and in the fellow eyes	3 years post IC-8 Apthera IOL implantation
Other	Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)	Mean monocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes	3 years post IC-8 Apthera IOL implantation
Other	Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA)	Mean distance-corrected intermediate visual acuity (DCIVA) and distance-corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes	3 years post IC-8 Apthera IOL implantation
Other	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	Uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) in IC-8 Apthera eyes and the fellow eyes may be evaluated in postoperative Manifest Refraction Spherical Equivalent groups: -1.01 D to more myopic, -1.00 D to -0.50 D, -0.49 D to -0.25 D, -0.24 D to 0.00 D, +0.01 D to +0.25 D, +0.26 D to more hyperopic.	3 years post IC-8 Apthera IOL implantation
Primary	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
Primary	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
Primary	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
Primary	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