A Phase 1/2 interventional study of Cryoanesthesia device and Lidocaine in Ocular Anesthesia, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by University of Michigan · Phase 1/2, Interventional, and Supportive care
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).
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
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 applied to the non-cryoanesthesia eye.
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
23 participants were recruited. Each participant received 1 cryoanesthesia intervention in one eye and one standard of care lidocaine intervention in their other eye.
| Milestone | Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds | Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds | Cyroanesthesia Device -10 Degrees Celsius for 10 Seconds | Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds |
|---|---|---|---|---|---|
| Started | 4 | 7 | 4 | 3 | 5 |
| Completed | 3 | 7 | 4 | 3 | 5 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 |
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.
| units on a scale | Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | Cyroanesthesia 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 | Standard of Care: Lidocaine |
|---|---|---|---|---|---|---|
| Subjective Injection Pain | 7.0 ± 1.5 | 3.1 ± 0.6 | 3.0 ± 1.1 | 1.8 ± 0.8 | 2.4 ± 0.8 | 2.3 ± 0.4 |
Collected over 7 days after treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Standard of Care: Lidocaine Gel | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 2 | 1 | 3 | 9 |
| >=65 years | 1 | 6 | 2 | 2 | 2 | 13 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|
| Female | 2 | 7 | 3 | 2 | 2 | 16 |
| Male | 1 | 0 | 1 | 1 | 3 | 6 |
| Race and Ethnicity Not Collected(Participants) | 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 |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
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