Cryoanesthesia for Intravitreal Injections

Study Overview
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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).

Official Title
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Cryoanesthesia for Intravitreal Injections

Conditions
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Ocular Anesthesia

Intervention / Treatment
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* Device: Cryoanesthesia device
* Drug: Lidocaine


Participation Criteria
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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 Exclusion Criteria: Unilateral disease Unable to provide consent Preexisting conjunctival, episcleral or scleral defects or disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoanesthesia Device -5 degrees Celsius for 10 seconds<br>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. | Device: Cryoanesthesia device<br>* 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.<br>|
| Experimental: Cryoanesthesia Device -5 degrees Celsius for 20 seconds<br>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. | Device: Cryoanesthesia device<br>* 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.<br>|
| Experimental: Cryoanesthesia Device -7 degrees Celsius for 20 seconds<br>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. | Device: Cryoanesthesia device<br>* 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.<br>|
| Experimental: Cryoanesthesia Device -10 degrees Celsius for 10 seconds<br>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. | Device: Cryoanesthesia device<br>* 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.<br>|
| Experimental: Cryoanesthesia Device -10 degrees Celsius for 20 seconds<br>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. | Device: Cryoanesthesia device<br>* 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.<br>|
| Active Comparator: Lidocaine<br>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. | Drug: Lidocaine<br>* Lidocaine applied to the non-cryoanesthesia eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Injection Pain | 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. | Immediately following the intravitreal injection |