Assessment of Novel Intraocular Injection Guide

Maturi, Raj K., M.D., P.C.

Status: Completed

Conditions: Retinal Disease

Treatments: Device: standard lid speculum; Device: intraocular injection guide

Study type: Interventional

Identifiers

NCT02315170

rkm006

Details and patient eligibility

About

To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.

Full description

This study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. The hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. The results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
• Injections in both eyes must be given on the same day
• Male or female age 18 years or older

Exclusion criteria

-Any condition or reason that precludes the subject's ability to comply with the study -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

intraocular injection guide

Experimental group

Description:

novel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye

Treatment:

Device: intraocular injection guide

standard lid speculum

Active Comparator group

Description:

Standard wire eyelid speculum

Treatment:

Device: standard lid speculum