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

Study Overview
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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.

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

Conditions
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Cataract Surgery

Intervention / Treatment
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* Device: etacoat


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: etacoat|Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specular microscopy to measure the preservation of endothelium |  | 90 days post surgery compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |