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

NCT03644875 | Completed

• 1 other identifier: CPH-401-201287
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Specular microscopy to measure the preservation of endothelium

  90 days post surgery compared to baseline

Secondary Outcomes (3)

• 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

Interventions

etacoat DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (1)

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

Vienna, Austria

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 23, 2018
• Study Start: June 28, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)