Clinical Evaluation of the RAVI-Guide

Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)

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

Study Overview

• Status: Completed
• Conditions: Retinal Diseases

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and Medical College of Wisconsin Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients 18 years of age or older who undergo intravitreal injection

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity associated with instrument type used for holding eyelids open during intravitreal injection	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.	Within 15 minutes of injection procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications associated with instrument use during intravitreal injection procedure	A questionnaire that queries about procedural complications will be completed by the treating physician.	Within 15 minutes of injection procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 19, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (ESTIMATE): July 22, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 22, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: PRO00021075