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

Sponsor
Croma-Pharma GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03644862
Collaborator
(none)
60
1
10.8
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: etafill

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Single Center, Non-comparative, 90-day Follow-up, Postmarket Clinical Investigation of Etafill in Patients With Cataract Surgery Via the Anterior Chamber
Actual Study Start Date :
Jan 29, 2019
Actual Primary Completion Date :
Dec 23, 2019
Actual Study Completion Date :
Dec 23, 2019

Outcome Measures

Primary Outcome Measures

  1. Specular microscopy to measure the preservation of endothelium cells [90 days post surgery compared to baseline]

Secondary Outcome Measures

  1. Specular microscopy to measure the corneal thickness [post surgery, 1 day and 90 days post surgery compared to baseline]

  2. Intraocular pressure measurement [post surgery, 1 day and 90 days post surgery compared to baseline]

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna Austria

Sponsors and Collaborators

  • Croma-Pharma GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Croma-Pharma GmbH
ClinicalTrials.gov Identifier:
NCT03644862
Other Study ID Numbers:
  • CPH-401-201285
First Posted:
Aug 23, 2018
Last Update Posted:
Jan 28, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2020