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OpenTrials
Completed

NCT Number: NCT03644875

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

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.

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Key information

Conditions

Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etacoat

Device

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

Primary outcomes

  1. Specular microscopy to measure the preservation of endothelium

    Time frame: 90 days post surgery compared to baseline

Secondary outcomes

  1. Specular microscopy to measure the corneal thickness

    Time frame: post surgery, 1 day and 90 days post surgery compared to baseline

  2. Intraocular pressure measurement

    Time frame: post surgery, 1 day and 90 days post surgery compared to baseline

  3. Questionnaire to assess the satisfaction with the application

    Time frame: 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 (best case) to cohesive (worst case).

Sponsors and collaborators

Lead sponsor

Croma-Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2018
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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