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This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.
The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etacoat | Device | Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Specular microscopy to measure the preservation of endothelium | 90 days post surgery compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Specular microscopy to measure the corneal thickness | post surgery, 1 day and 90 days post surgery compared to baseline | |
| Intraocular pressure measurement | post surgery, 1 day and 90 days post surgery compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The study patients will be recruited by the investigator, among patients scheduled to receive a standard cataract surgery taking inclusion and exclusion criteria into account. The investigator may also offer participation in the study to potential candidates identified in their patient database.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital | Vienna | Austria |
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| Questionnaire to assess the satisfaction with the application | Questionnaire contains the subjective evaluation by the investigator of the IMD's rheological properties as well as the maintenance of the patient's anterior chamber and dome. Scale for the chamber and dome maintenance ranges from flat (worst case) to full chamber (best case) maintained. Scale for rheological properties ranges from dispersive (best case) to cohesive (worst case). | day 0 |