Assessment of Novel Intraocular Injection Guide

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

Detailed Description
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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

Official Title
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Assessment of Novel Intraocular Injection Guide

Conditions
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Retinal Disease

Intervention / Treatment
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* Device: intraocular injection guide
* Device: standard lid speculum


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intraocular injection guide<br>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 | Device: intraocular injection guide<br>* The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection<br>|
| Active Comparator: standard lid speculum<br>Standard wire eyelid speculum | Device: standard lid speculum<br>* standard wire lid speculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | 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). | one time for about 30 sec or less | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, age-related macular edema