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Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber | Clinical Trials | Clareo Health

COMPLETED

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

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

NCT03644875•Croma-Pharma GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

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

Vienna, Austria

Key Dates

Start Date

June 28, 2018

Primary Completion Date

May 16, 2019

Completion Date

May 16, 2019

Last Updated

December 10, 2024

Enrollment

ACTUAL participants

Conditions

Cataract Surgery

Interventions

etacoat

DEVICE

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

View study

RECRUITINGNA

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

NCT07178639

Macular OedemaCataract Surgery+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

Oral vs IV Sedation for Cataract Surgery in Older Adults

Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options

Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System

Teleconference-Based Structed Counseling