Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etafill in patients undergoing cataract surgery.
The performance is measured by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafill | Device | Etafill is a HA formulation intended to be used in opthalmic anterior segment cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Specular microscopy to measure the preservation of endothelium cells | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital | Vienna | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 (worst case) to cohesive (best case). | day 0 |