Assessment of Novel Intraocular Injection Guide

Not Applicable

Completed

• Conditions: Retinal Disease
• Interventions: Device: standard lid speculum; Device: intraocular injection guide

• Registration Number: NCT02315170
• Lead Sponsor: Maturi, Raj K., M.D., P.C.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2020-09-18
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Results First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard lid speculum	standard lid speculum	Standard wire eyelid speculum
intraocular injection guide	intraocular injection guide	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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	one time for about 30 sec or less	The VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The scale scores range from 0mm (no pain) to 100mm (very severe pain). The patient marks on the line the point that they feel represents their perception of their current state (no pain to very severe pain).

Trial Locations

Locations (1)

Raj K Maturi MD PC; 🇺🇸 Indianapolis, Indiana, United States