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

Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644875
• Other study ID #: CPH-401-201287
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

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