CataractNCT05758883
Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
An observational study of Cataract and Presbyopia, run by AcuFocus, Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- How many people
- 196 participants
- Where
- 20 sitesUnited States
- Study dates
- 12 Jan 2023to 16 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Chu Vision Institute
Bloomington, Minnesota, 55420
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Hoopes Vision
Draper, Utah, 84021
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525
Physicians Protocol
Greensboro, North Carolina, 27408
Baylor College of Medicine
Houston, Texas, 77030
Harvard Eye Associates
Laguna Hills, California, 92653
Altos Eye Physicians
Los Altos, California, 94024
Advanced Vision Care
Los Angeles, California, 90067
Virginia Eye Consultants
Norfolk, Virginia, 23502
Utah Eye Centers
Ogden, Utah, 84403
Kugler Vision
Omaha, Nebraska, 68118
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603
Parkhurst NuVision
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Pepose Vision Institute
St Louis, Missouri, 63128
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Tucson, Arizona, 85704
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: Post-approval Follow-up Study of the IC-8 Apthera IOL
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
Read the 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.
- Conditions
- Cataract, Presbyopia
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 3 years post IC-8 Apthera IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start12 Jan 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758883
- Sponsor's protocol ID
- SAIL-101-PAS
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval Follow-up Study of the IC-8 Apthera IOL
- ClinicalTrials.gov ID
- NCT05758883
- Acronym / sponsor ID
- SAIL-101-PAS
- Conditions
- Cataract, Presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of secondary surgical interventions (SSIs)
Time frame: 3 years post IC-8 Apthera IOL implantation
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
Rates of other serious adverse events
Time frame: 3 years post IC-8 Apthera IOL implantation
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
Rates of ocular adverse events
Time frame: 3 years post IC-8 Apthera IOL implantation
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
Rates of subjective visual disturbances
Time frame: 3 years post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Presbyopia, run by AcuFocus, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of secondary surgical interventions (SSIs) (time frame: 3 years post IC-8 Apthera IOL implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.