Cryoanesthesia for Intravitreal Injections

University of Michigan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Anesthesia

Treatments: Device: Cryoanesthesia device; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02872012

HUM00105826

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 6 patient groups

Cryoanesthesia Device -5 degrees Celsius for 10 seconds

Experimental group

Description:

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.

Treatment:

Device: Cryoanesthesia device

Cryoanesthesia Device -5 degrees Celsius for 20 seconds

Experimental group

Description:

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.

Treatment:

Device: Cryoanesthesia device

Cryoanesthesia Device -7 degrees Celsius for 20 seconds

Experimental group

Description:

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.

Treatment:

Device: Cryoanesthesia device

Cryoanesthesia Device -10 degrees Celsius for 10 seconds

Experimental group

Description:

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.

Treatment:

Device: Cryoanesthesia device

Cryoanesthesia Device -10 degrees Celsius for 20 seconds

Experimental group

Description:

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.

Treatment:

Device: Cryoanesthesia device

Lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine