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

Croma-Pharma

Status: Completed

Conditions: Cataract Surgery

Treatments: Device: etacoat

Study type: Observational

Funder types: Industry

Identifiers

NCT03644875

CPH-401-201287

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients indicated for cataract surgery via the anterior chamber
• A negative urine pregnany 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

• Patient who are known to be hypersensitive to HPMC 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