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Assessment of Novel Intraocular Injection Guide

Primary Purpose

Retinal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intraocular injection guide
standard lid speculum
Sponsored by
Maturi, Raj K., M.D., P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinal Disease focused on measuring diabetic retinopathy, age-related macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • Raj K Maturi MD PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intraocular injection guide

standard lid speculum

Arm 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

Standard wire eyelid speculum

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 9, 2014
Last Updated
May 3, 2021
Sponsor
Maturi, Raj K., M.D., P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT02315170
Brief Title
Assessment of Novel Intraocular Injection Guide
Official Title
Assessment of Novel Intraocular Injection Guide
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maturi, Raj K., M.D., P.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
Keywords
diabetic retinopathy, age-related macular edema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraocular injection guide
Arm Type
Experimental
Arm 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
Arm Title
standard lid speculum
Arm Type
Active Comparator
Arm Description
Standard wire eyelid speculum
Intervention Type
Device
Intervention Name(s)
intraocular injection guide
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
standard lid speculum
Intervention Description
standard wire lid speculum
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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).
Time Frame
one time for about 30 sec or less

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj K Maturi, MD
Organizational Affiliation
Raj K. Maturi, MD, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raj K Maturi MD PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Assessment of Novel Intraocular Injection Guide

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