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Assessment of Novel Intraocular Injection Guide

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ClinicalTrials.gov Identifier: NCT02315170
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, 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.

Condition or disease Intervention/treatment Phase
Retinal Disease Device: intraocular injection guide Device: standard lid speculum Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Assessment of Novel Intraocular Injection Guide
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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

Active Comparator: standard lid speculum
Standard wire eyelid speculum
Device: standard lid speculum
standard wire lid speculum




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 4 months ]
    The VAS is a horizontal line anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state (no pain to very severe pain)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315170


Locations
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United States, Indiana
Raj K Maturi MD PC
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Maturi, Raj K., M.D., P.C.
Investigators
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Principal Investigator: Raj K Maturi, MD Raj K. Maturi, MD, PC

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Responsible Party: Raj K. Maturi, MD, President, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT02315170     History of Changes
Other Study ID Numbers: rkm006
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.:
diabetic retinopathy
age-related macular edema

Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases