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Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

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ClinicalTrials.gov Identifier: NCT03314766
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
AcuFocus, Inc.

Brief 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.

Condition or disease Intervention/treatment
Cataract Presbyopia Device: IC-8 IOL

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : October 20, 2018

Group/Cohort Intervention/treatment
IC-8 IOL
Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029
Device: IC-8 IOL
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




Primary Outcome Measures :
  1. TCNVA [ Time Frame: 12 months ]
    Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.


Secondary Outcome Measures :
  1. Overall Satisfaction [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  1. 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.
  2. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
  3. Signed informed consent.

Exclusion Criteria:

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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314766


Contacts
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Contact: Nicholas Tarantino, OD 9495859511 ntarantino@acufocus.com
Contact: Srividhya Vilupuru, OD, PhD 9495859511 svilupuru@acufocus.com

Locations
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Germany
Augen Zentrum Nordwest Recruiting
Ahaus, Germany, 48683
Contact: Susanne Barte-Lohmann         
Principal Investigator: Stefanie Schmickler, M.D.         
Universitats-Augenklinik, Department of Ophthalmology Not yet recruiting
Bochum, Germany, 44892
Contact: Sabine Buchner         
Principal Investigator: Prof. H. Burkhard Dick, M.D.         
Italy
San Bassano Hospital Not yet recruiting
Bassano del Grappa, Italy, 36061
Contact: Franca Oro         
Principal Investigator: Simonetta Morselli, M.D.         
Sub-Investigator: Antonio Toso, M.D.         
Centro Microchirurgia Ambulatoriale Recruiting
Monza, Italy, 20900
Contact: Erika De Lorenzo         
Principal Investigator: Matteo Piovella, M.D.         
Norway
Ifocus Øyeklinikk Not yet recruiting
Haugesund, Norway, 5527
Contact: Steffen Østenstad         
Principal Investigator: Kjell Gundersen, M.D.         
Spain
QVision (Unidad Oftalmología Hospital Virgen del Mar) Recruiting
Almería, Spain, 04120
Contact: Manuel Rodriguez         
Principal Investigator: Joaquín Fernández, M.D.         
Hospital Universitario Donostia, Servicio de Oftalmología Recruiting
San Sebastian, Spain, 20014
Contact: Javier Mendicute del Barrio         
Principal Investigator: Javier Mendicute del Barrio, M.D.         
Sponsors and Collaborators
AcuFocus, Inc.
Investigators
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Study Director: Nicholas Tarantino, OD

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Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT03314766     History of Changes
Other Study ID Numbers: IC-8 203-LTCA
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors