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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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etacoat

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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CPH-401-201287

Identifier Type: -

Identifier Source: org_study_id