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Cataract Surgery

Study of Etafill in Patients With Cataract Surgery Via the Anterior Chamber

Sponsored by Croma-Pharma GmbH

About this trial

Last updated 5 years ago

Study ID

CPH-401-201285

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status