Assessment of Novel Intraocular Injection Guide

Retinal Disease Clinical Trial

Official title:

Assessment of Novel Intraocular Injection Guide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315170
• Other study ID #: rkm006
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2021
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• intraocular injection guide
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
standard wire lid speculum

Locations

Country	Name	City	State
United States	Raj K Maturi MD PC	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Maturi, Raj K., M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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