Ocular AnesthesiaPhase 1/2NCT02872012

Cryoanesthesia for Intravitreal Injections

A Phase 1/2 study testing Cryoanesthesia device and Lidocaine in people with Ocular Anesthesia, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Ocular Anesthesia
What is being tested?: Cryoanesthesia device and Lidocaine
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Jun 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Unilateral disease
Unable to provide consent
Preexisting conjunctival, episcleral or scleral defects or disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Kellogg Eye Center
Ann Arbor, Michigan, 48105

Other trials in United States

About this study

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).

Conditions: Ocular Anesthesia
Being tested: Cryoanesthesia device, Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cryoanesthesia deviceDevice
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.
LidocaineDrug
Lidocaine applied to the non-cryoanesthesia eye.

Study groups in NCT02872012
Study group	Role	What they receive
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. Receives: Device: Cryoanesthesia 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. Receives: Device: Cryoanesthesia 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. Receives: Device: Cryoanesthesia 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. Receives: Device: Cryoanesthesia device
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. Receives: Device: Cryoanesthesia 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. Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately following the intravitreal injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2018

First posted18 Aug 2016 (estimated)
Study startMar 2016
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ocular AnesthesiaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02872012
Sponsor's protocol ID: HUM00105826
Status last verified: Sep 2019
First submitted: 2 Jun 2016
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 32446842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ocular Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cryoanesthesia for Intravitreal Injections
ClinicalTrials.gov ID: NCT02872012
Acronym / sponsor ID: HUM00105826
Conditions: Ocular Anesthesia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 18 Aug 2016 (estimated)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cryoanesthesia Device -5 degrees Celsius for 10 seconds	Experimental	Device: Cryoanesthesia deviceAll 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	Device: Cryoanesthesia deviceAll 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	Device: Cryoanesthesia deviceAll 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	Device: Cryoanesthesia deviceAll 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 20 seconds	Experimental	Device: Cryoanesthesia deviceAll 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	Drug: LidocaineParticipants 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.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

Unilateral disease
Unable to provide consent
Preexisting conjunctival, episcleral or scleral defects or disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cryoanesthesia deviceThe 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.	Device	Cryoanesthesia Device -10 degrees Celsius for 10 seconds, Cryoanesthesia Device -10 degrees Celsius for 20 seconds, Cryoanesthesia Device -5 degrees Celsius for 10 seconds, Cryoanesthesia Device -5 degrees Celsius for 20 seconds, Cryoanesthesia Device -7 degrees Celsius for 20 seconds
LidocaineLidocaine applied to the non-cryoanesthesia eye.	Drug	Lidocaine

Primary outcome

Subjective Injection Pain
Time frame: 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.

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds	4	3
Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds	7	7
Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds	4	4
Cyroanesthesia Device -10 Degrees Celsius for 10 Seconds	3	3
Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds	5	5

Primary outcome: Subjective Injection Pain

Time frame: Immediately following the intravitreal injection. Mean (Standard Error). Unit: units on a scale

Measure	Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds n = 3	Cyroanesthesia Device -5 Degrees Celsius for 20 Seconds n = 7	Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds n = 4	Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds n = 3	Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds n = 5	Standard of Care: Lidocaine n = 22
Value	7.0 (1.5)	3.1 (0.6)	3.0 (1.1)	1.8 (0.8)	2.4 (0.8)	2.3 (0.4)

Adverse events

Time frame: 7 days after treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Standard of Care: Lidocaine Gel	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32446842Besirli 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anjali R Shah, MD principal investigator

Instructor in Ophthalmology and Visual Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cryoanesthesia device and Lidocaine in people with Ocular Anesthesia, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Injection Pain (time frame: Immediately following the intravitreal injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02872012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.