CataractNCT03314766
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
An observational study of Cataract and Presbyopia, run by AcuFocus, Inc. at 7 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- IC-8 IOL
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 20 Oct 2017to 27 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for this study will be recruited from the clinical sites that participated in the prior open-label, multicenter study (protocol ACU-P14-029). Anticipated study sample size of no more than 80 patients should effectively demonstrate the long-term clinical acceptability of the IC-8 IOL implanted in aphakic patients. Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.
Who may be able to join
- Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
- Signed informed consent.
Who cannot join
- 1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Germany2 sites
Augen Zentrum Nordwest
Ahaus, 48683
Universitats-Augenklinik, Department of Ophthalmology
Bochum, 44892
Italy2 sites
San Bassano Hospital
Bassano del Grappa, 36061
Centro Microchirurgia Ambulatoriale
Monza, 20900
Spain2 sites
QVision (Unidad Oftalmología Hospital Virgen del Mar)
Almería, 04120
Hospital Universitario Donostia, Servicio de Oftalmología
Donostia / San Sebastian, 20014
About this study
The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.
Read the detailed description
This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.
The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.
- Conditions
- Cataract, Presbyopia
- Being tested
- IC-8 IOL
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC-8 IOLDevice
Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation
| Study group | Role | What they receive |
|---|---|---|
| IC-8 IOL | Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 Receives: Device: IC-8 IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCNVA
Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.
Measured: 12 months
Secondary outcomes (1)
Overall Satisfaction
Overall satisfaction with postoperative vision at least 12 months post-operatively, with an outcome of objective of 85% or more being either very satisfied or satisfied.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start20 Oct 2017
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Tarantino, OD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314766
- Sponsor's protocol ID
- IC-8 203-LTCA
- Status last verified
- Jul 2018
- First submitted
- 16 Oct 2017
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
- ClinicalTrials.gov ID
- NCT03314766
- Acronym / sponsor ID
- IC-8 203-LTCA
- Conditions
- Cataract, Presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 19 Oct 2017 (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 clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.
Detailed description
This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.
The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-8 IOL | – | Device: IC-8 IOLPatients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for this study will be recruited from the clinical sites that participated in the prior open-label, multicenter study (protocol ACU-P14-029). Anticipated study sample size of no more than 80 patients should effectively demonstrate the long-term clinical acceptability of the IC-8 IOL implanted in aphakic patients. Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.
Key inclusion criteria (3 listed)
- Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
- Signed informed consent.
Key exclusion criteria (1 listed)
- 1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC-8 IOLPatients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation | Device | IC-8 IOL |
Primary outcome
TCNVA
Time frame: 12 months
Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.
1 secondary outcome
Overall Satisfaction
Time frame: 12 months
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 13 May 2022.
- Individual participant dataSharing planned: No
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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.
Nicholas Tarantino, OD study director
7 sites in 4 countries: 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 7 sites in 4 countries.
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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Spain, Norway. 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?
TCNVA (time frame: 12 months). 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 13 May 2022.