Status:
COMPLETED
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Lead Sponsor:
AcuFocus, Inc.
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
18+ years
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.
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 nin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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. -
Key Trial Info
Start Date :
October 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03314766
Start Date
October 20 2017
End Date
November 27 2018
Last Update
May 13 2022
Active Locations (7)
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1
Augen Zentrum Nordwest
Ahaus, Germany, 48683
2
Universitats-Augenklinik, Department of Ophthalmology
Bochum, Germany, 44892
3
San Bassano Hospital
Bassano del Grappa, Italy, 36061
4
Centro Microchirurgia Ambulatoriale
Monza, Italy, 20900