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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoanesthesia Device -5 degrees Celsius for 10 seconds | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoanesthesia device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anjali R Shah, MD | Instructor in Ophthalmology and Visual Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32446842 | Derived | Besirli CG, Smith SJ, Zacks DN, Gardner TW, Pipe KP, Musch DC, Shah AR. Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections. Ophthalmol Retina. 2020 Oct;4(10):979-986. doi: 10.1016/j.oret.2020.04.001. Epub 2020 Apr 15. |
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23 participants were recruited. Each participant received 1 cryoanesthesia intervention in one eye and one standard of care lidocaine intervention in their other eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| FG001 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds.. |
| FG002 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| FG003 | Cyroanesthesia 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| FG004 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Immediately following the intravitreal injection |
|
7 days after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anjali Shah | University of Michigan Kellogg Eye Center | 734-763-8122 | arshah@med.umich.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2018 | May 21, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Cryoanesthesia Device -10 degrees Celsius for 20 seconds | Experimental | 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 | Active Comparator | 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. |
|
| Lidocaine | Drug | Lidocaine applied to the non-cryoanesthesia eye. |
|
| BG001 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| BG002 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| BG003 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| BG004 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Cyroanesthesia 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| OG002 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| OG003 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| OG004 | 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. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. |
| OG005 | Standard of Care: 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. |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 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. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | 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. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | 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. 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. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | Standard of Care: Lidocaine Gel | Participants randomized to this arm will have their other eye receive anesthesia via one current standard of care treatment method (lidocaine gel) prior to receiving an intravitreal injection. Lidocaine gel: Lidocaine gel applied to the non-cryoanesthesia eye. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Aniline Compounds |
| D000588 | Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|