Assessment of Novel Intraocular Injection Guide

• Sponsor: Maturi, Raj K., M.D., P.C. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02315170
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Assessment of Novel Intraocular Injection Guide
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raj K Maturi MD PC	Indianapolis	Indiana	United States	46290

Sponsors and Collaborators

• Maturi, Raj K., M.D., P.C.

Investigators

• Principal Investigator: Raj K Maturi, MD, Raj K. Maturi, MD, PC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raj Maturi, President, Maturi, Raj K., M.D., P.C.
• ClinicalTrials.gov Identifier: NCT02315170
• Other Study ID Numbers: rkm006
• First Posted: Dec 11, 2014
• Last Update Posted: May 5, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raj Maturi, President, Maturi, Raj K., M.D., P.C.: diabetic retinopathy; age-related macular edema
• Additional relevant MeSH terms: Retinal Diseases

Study Results

Participant Flow

Recruitment Details	all subjects presenting for bilateral injection were offered the chance to participate in this clinical trail
Pre-assignment Detail	eyes were chosen for the novel guide or standard lid speculum using a randomizing table

Arm/Group Title	Intraocular Injection Guide	Standard Lid Speculum
Arm/Group 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 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 wire eyelid speculum standard lid speculum: standard wire lid speculum
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Only subjects needing bilateral ocular injections were included in the study. The total number of participants was 50 (100 eyes). Baseline characteristics were identical in both groups. One eye received the treatment with the injection guide while the fellow eye received the treatment with a standard lid speculum.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 40%
>=65 years	30 60%
Sex: Female, Male (Count of Participants)
Female	35 70%
Male	15 30%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Total number of subjects is 50 - however as the system here is designed for whole body count (not bilateral organs such as eyes), the total number will appear to be double of actual number of subjects.

Arm/Group Title	Intraocular Injection Guide	Standard Lid Speculum
Arm/Group 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 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 wire eyelid speculum standard lid speculum: standard wire lid speculum
Measure Participants	50	50
Measure eyes	50	50
Median (Standard Deviation) [mm on the VAS]	14 (6)	33 (7)

Adverse Events

Arm/Group Title	Intraocular Injection Guide		Standard Lid Speculum
Arm/Group 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 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 wire eyelid speculum standard lid speculum: standard wire lid speculum
All Cause Mortality
	Intraocular Injection Guide		Standard Lid Speculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	Intraocular Injection Guide		Standard Lid Speculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Intraocular Injection Guide		Standard Lid Speculum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

This is a small one event study (about 10 min duration). The participant evaluates which speculum (used for about 30 sec or less) during the procedure provides better comfort. Thus, long term evaluation has not been peformed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.