Clinical Evaluation of the RAVI-Guide

Completed

• Conditions: Retinal Diseases

• Registration Number: NCT02196584
• Lead Sponsor: Medical College of Wisconsin

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-19
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Study Start: 2014-08
• Primary Completion: 2015-09
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Froedtert and Medical College of Wisconsin Eye Institute; 🇺🇸 Milwaukee, Wisconsin, United States