Cataract Surgery
Conditions
Brief summary
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.
Interventions
DEVICEetafill
Etafill is a HA formulation intended to be used in opthalmic anterior segment cataract surgery.
Sponsors
Croma-Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients indicated for cataract surgery via the anterior chamber * A negative urine pregnancy test at Visit 1 or 2 * Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent
Exclusion criteria
* Patients with a known hypersensitivity to HA or other components of the device. * Patients with corneal scars or corneal dystrophies interfering with study measurements * Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator) * Any other condition that in the opinion of the investigator would interfere with the participation in this investigation * Any person dependent on the investigator or employees of the investigation site institution or the Sponsor. * Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study * Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specular microscopy to measure the preservation of endothelium cells | 90 days post surgery compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Questionnaire to assess the satisfaction with the application | day 0 | 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). |
Countries
Austria
Outcome results
None listed