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OpenTrials
Completed

NCT Number: NCT02315170

Assessment of Novel Intraocular Injection Guide

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

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Key information

Conditions

Retinal Disease Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

intraocular injection guide

Device

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

standard lid speculum

Device

standard wire lid speculum

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2014
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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