Cryoanesthesia for Intravitreal Injections
1 other identifier
interventional
23
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedResults Posted
Study results publicly available
July 16, 2019
CompletedSeptember 17, 2019
September 1, 2019
2.3 years
June 2, 2016
May 28, 2019
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
Cryoanesthesia Device -5 degrees Celsius for 10 seconds
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALAll 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 COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unilateral disease
- Unable to provide consent
- Preexisting conjunctival, episcleral or scleral defects or disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Related Publications (1)
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.
PMID: 32446842DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anjali Shah
- Organization
- University of Michigan Kellogg Eye Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anjali R Shah, MD
Instructor in Ophthalmology and Visual Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Ophthalmology and Visual Sciences
Study Record Dates
First Submitted
June 2, 2016
First Posted
August 18, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
September 17, 2019
Results First Posted
July 16, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share