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

A Prospective, Single Center, Non-comparative, 90-day Follow-up, Postmarket Clinical Investigation of Etafill in Patients With Cataract Surgery Via the Anterior Chamber

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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: etafill

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Specular microscopy to measure the preservation of endothelium cells	90 days post surgery compared to baseline

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CPH-401-201285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No