Cryoanesthesia for Intravitreal Injections

Phase 1

Completed

• Conditions: Ocular Anesthesia
• Interventions: Device: Cryoanesthesia device; Drug: Lidocaine

• Registration Number: NCT02872012
• Lead Sponsor: University of Michigan

Brief Summary

The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the surface of the eye immediately prior to intraocular injections.

The investigators plan to carry out a pilot study to collect preliminary data on the effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal injections (IVT).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Results First Submitted: 2019-05-28
• Results First Submitted QC: 2019-06-25
• Results First Posted: 2019-07-16
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Bilateral macular disease due to either exudative macular degeneration or diabetic retinopathy requiring bilateral intravitreal injections
• Have had at least one prior intravitreal injection
• Able to give informed consent

Exclusion Criteria

• Unilateral disease
• Unable to provide consent
• Preexisting conjunctival, episcleral or scleral defects or disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoanesthesia Device -5 degrees Celsius for 10 seconds	Cryoanesthesia device	All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device.
Cryoanesthesia Device -5 degrees Celsius for 20 seconds	Cryoanesthesia device	All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device.
Cryoanesthesia Device -7 degrees Celsius for 20 seconds	Cryoanesthesia device	All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device.
Cryoanesthesia Device -10 degrees Celsius for 10 seconds	Cryoanesthesia device	All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device.
Cryoanesthesia Device -10 degrees Celsius for 20 seconds	Cryoanesthesia device	All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device.
Lidocaine	Lidocaine	Participants randomized to this arm will have their other eye receive anesthesia via the current standard of care treatment method (lidocaine) prior to receiving an intravitreal injection. Lidocaine: Lidocaine will be applied to the non-cryoanesthesia eye.

Primary Outcome Measures

Name	Time	Method
Subjective Injection Pain	Immediately following the intravitreal injection	Immediately after receiving the intravitreal injection, patient's will be asked to rate their pain on the Visual Analogue (Pain) Scale. The scale ranges from 0 to 10. 0 meaning no pain and 10 meaning the worst possible pain.

Trial Locations

Locations (1)

Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States