Clinical Evaluation of the RAVI-Guide

Retinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196584
• Other study ID #: PRO00021075
• Status: Completed
• Phase: N/A
• First received: July 19, 2014
• Last updated: June 22, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinal Diseases

Locations

Country	Name	City	State
United States	Froedtert and Medical College of Wisconsin Eye Institute	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes