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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03644875
Other study ID # CPH-401-201287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 28, 2018
Est. completion date May 16, 2019

Study information

Verified date August 2019
Source Croma-Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 16, 2019
Est. primary completion date May 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
etacoat
Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery.

Locations

Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Sponsors (1)

Lead Sponsor Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Specular microscopy to measure the preservation of endothelium 90 days post surgery compared to baseline
Secondary Specular microscopy to measure the corneal thickness post surgery, 1 day and 90 days post surgery compared to baseline
Secondary Intraocular pressure measurement post surgery, 1 day and 90 days post surgery compared to baseline
Secondary 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 (best case) to cohesive (worst case).
day 0
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