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Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Device | No study treatments will be administered during this study. However, data will be collected from medical records of patients who have been treated with the subject device of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Symptoms | Patient questionnaires | 3month postoperative |
| Surgeon Experience | Questionnaire | 3month postoperative |
| Visual Acuity | Visual Acuity will be collected with standard clinical charts. | 3month postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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A pre-existing population of subjects bilaterally implanted with the PC IOL at approximately 20 sites in Europe and Asia Pacific. Bilateral pseudophakic subjects implanted with the TECNIS PC IOL will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision, Inc. Clinical Trial | Johnson & Johnson Surgical Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Eye Institute | Chatswood | New South Wales | 2067 | Australia | ||
| Sunshine Eye Clinic |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| Birtinya |
| Queensland |
| 4575 |
| Australia |
| The Queensland Eye Institute Foundation | Woolloongabba | Queensland | 4102 | Australia |
| Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute | Vienna | 1140 | Austria |
| CHU Morvan Brest | Brest | 29609 | France |
| Clinique Juge Marseille | Marseille | 13008 | France |
| Augenklinik Ahaus GmbH & Co. KG | Ahaus | 48683 | Germany |
| Augenklinik Dardenne | Bonn | 53177 | Germany |
| Narayana Nethralaya | Bengaluru | India |
| The Eye Foundation | Coimbatore | India |
| Centre for Sight Eye Institute | New Delhi | 110029 | India |
| All India Institute of Medical Sciences (AIIMS) | New Delhi | India |
| Oogziekenhuis Rotterdam | Rotterdam | 3011 BH | Netherlands |
| ETZ | Tilburg | 5022 GC | Netherlands |
| Kim's eye clinic | Seoul | 7301 | South Korea |
| Korea Uni.Kuro | Seoul | 8308 | South Korea |
| Clinica Oftalmologica Diez del Corral | Madrid | 28016 | Spain |
| Mirzana IOA | Madrid | 28035 | Spain |
| Vithas Alicante | Madrid | 28043 | Spain |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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