Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- TCNVA [12 months]
Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.
Secondary Outcome Measures
- Overall Satisfaction [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
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Signed informed consent.
Exclusion Criteria:
- 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. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | |
| 5 | Ifocus Øyeklinikk | Haugesund | Norway | 5527 | |
| 6 | QVision (Unidad Oftalmología Hospital Virgen del Mar) | Almería | Spain | 04120 | |
| 7 | Hospital Universitario Donostia, Servicio de Oftalmología | San Sebastian | Spain | 20014 |
Sponsors and Collaborators
- AcuFocus, Inc.
Investigators
- Study Director: Nicholas Tarantino, OD,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC-8 203-LTCA