Clincosm LogoSign in Get a demo

Clinical Evaluation of the RAVI-Guide

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT02196584
Collaborator
(none)
55
Enrollment
1
Location
22
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    55 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Pain severity associated with instrument type used for holding eyelids open during intravitreal injection [Within 15 minutes of injection procedure]

      A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity.

    Secondary Outcome Measures

    1. Procedural complications associated with instrument use during intravitreal injection procedure [Within 15 minutes of injection procedure]

      A questionnaire that queries about procedural complications will be completed by the treating physician.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Froedtert and Medical College of Wisconsin Eye Institute Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    • Principal Investigator: Dennis P Han, MD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dennis Han, Professor of Ophthalmology, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT02196584
    Other Study ID Numbers:
    • PRO00021075
    First Posted:
    Jul 22, 2014
    Last Update Posted:
    Jun 23, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Retinal Diseases

    Study Results

    No Results Posted as of Jun 23, 2016