Cryoanesthesia for Intravitreal Injections

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Ocular Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cryoanesthesia Device -5 degrees Celsius for 10 seconds

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.

Group Type EXPERIMENTAL

Cryoanesthesia device

Intervention Type DEVICE

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Cryoanesthesia Device -5 degrees Celsius for 20 seconds

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.

Group Type EXPERIMENTAL

Cryoanesthesia device

Intervention Type DEVICE

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Cryoanesthesia Device -7 degrees Celsius for 20 seconds

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.

Group Type EXPERIMENTAL

Cryoanesthesia device

Intervention Type DEVICE

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Cryoanesthesia Device -10 degrees Celsius for 10 seconds

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.

Group Type EXPERIMENTAL

Cryoanesthesia device

Intervention Type DEVICE

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Cryoanesthesia Device -10 degrees Celsius for 20 seconds

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.

Group Type EXPERIMENTAL

Cryoanesthesia device

Intervention Type DEVICE

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

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.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine applied to the non-cryoanesthesia eye.

Interventions

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Cryoanesthesia device

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Intervention Type DEVICE

Lidocaine

Lidocaine applied to the non-cryoanesthesia eye.

Intervention Type DRUG

Eligibility Criteria

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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