Ocular Anesthesia
Conditions
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).
Interventions
DEVICECryoanesthesia 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.
DRUGLidocaine
Lidocaine applied to the non-cryoanesthesia eye.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
23 participants were recruited. Each participant received 1 cryoanesthesia intervention in one eye and one standard of care lidocaine intervention in their other eye.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 7 |
| 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. | 4 |
| 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. | 3 |
| 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. | 5 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds | Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds | Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds | Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 3 Participants | 2 Participants | 2 Participants | 16 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 7 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 22 |
| other Total, other adverse events | 0 / 3 | 0 / 7 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 22 |
| serious Total, serious adverse events | 0 / 3 | 0 / 7 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 22 |
Outcome results
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.
Time frame: Immediately following the intravitreal injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | Subjective Injection Pain | 7.0 units on a scale | Standard Error 1.5 |
| Cyroanesthesia Device -5 Degrees Celsius for 20 Seconds | Subjective Injection Pain | 3.1 units on a scale | Standard Error 0.6 |
| Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds | Subjective Injection Pain | 3.0 units on a scale | Standard Error 1.1 |
| Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds | Subjective Injection Pain | 1.8 units on a scale | Standard Error 0.8 |
| Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds | Subjective Injection Pain | 2.4 units on a scale | Standard Error 0.8 |
| Standard of Care: Lidocaine | Subjective Injection Pain | 2.3 units on a scale | Standard Error 0.4 |