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

Completed

• Conditions: Cataract Surgery

• Registration Number: NCT03644862
• Lead Sponsor: Croma-Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Study Start: 2019-01-29
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specular microscopy to measure the preservation of endothelium cells	90 days post surgery compared to baseline

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital; 🇦🇹 Vienna, Austria