Clinical Evaluation of the RAVI-Guide

NCT ID: NCT02196584

Last Updated: 2016-06-23

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

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

Brief Summary

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Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections

Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach

Detailed Description

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Conditions

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Retinal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients age 18 years or older who undergo intravitreal injection for clinical indications.

Exclusion Criteria

* Patients under the age of 18 years
* Patients unable to give informed consent
* Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection
* Disorders that preclude the ability to assess for complications of intravitreal injection
* Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus
* Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Dennis Han

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis P Han, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert and Medical College of Wisconsin Eye Institute

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00021075

Identifier Type: -

Identifier Source: org_study_id

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