Anesthesia, LocalPhase 1/2COOL-1NCT03732287
Cooling Anesthesia for Intravitreal Injection
A Phase 1/2 study testing Cooling Anesthesia in people with Anesthesia, Local and Intravitreal Injection, run by Recens Medical, Inc. at 2 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Anesthesia, Local, Intravitreal Injection, Macular Degeneration
- What is being tested?
- Cooling Anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2018to 26 Apr 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women > 18 years old at screening visit.
- Men and women who are undergoing intravitreal injections in either one eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle.
- Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit.
- Subject is willing and able to sign the study written informed consent form (ICF).
Who cannot join
- History of presence of scleromalacia
- Preexisting conjunctival, episcleral or scleral defects
- Less than 18 years of age
- Unable to provide informed consent
- Has received less than 3 injections in the study eye
- Active severe eye disease not controlled with artificial tears and requiring Restasis or Xiidra drops.
Show all 10Show fewer
- History of Endophthalmitis with intravitreal injection
- History of uveitis
- History of retinal detachment in either eye
- History of vitrectomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Consultants of Houston
Houston, Texas, 77030
Sierra Eye Associates
Reno, Nevada, 89502
About this study
Official title: A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)
The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.
Read the detailed description
Intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema. There is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. Current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia.
Recens Medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye This device cools to a temperature around -5 to -10 degrees Celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. The value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections.
This device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care.
This dose escalation study will test various temperatures and duration of temperatures to evaluate for safety as well as determine the optimal temperature for anesthesia during intravitreal injection.
- Being tested
- Cooling Anesthesia
- Keywords
- intravitreal injection, anesthesia, macular degeneration, diabetic macular edema
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling AnesthesiaDevice
Application of cooling anesthesia device prior to intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| -5 degrees Celsius for 10 seconds | Experimental | Not described Receives: Device: Cooling Anesthesia |
| -5 degrees Celsius for 20 seconds | Experimental | Not described Receives: Device: Cooling Anesthesia |
| -10 degrees Celsius for 10 seconds | Experimental | Not described Receives: Device: Cooling Anesthesia |
| -10 degrees Celsius for 20 seconds | Experimental | Not described Receives: Device: Cooling Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain
Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.
Measured: 24-48 hours after injection
Number of patients with treatment adverse events as measured by slit lamp examination
Full slit lamp examination of anterior and posterior segment after intravitreal injection
Measured: 30 minutes after injection
Secondary outcomes (2)
Subject response to needle penetration
subject response to needle penetration as evaluated by physician
Measured: Intraoperative (During injection)
Time to perform intravitreal injection
Time to perform injection, measured from beginning of anesthesia to intravitreal injection
Measured: Intraoperative (injection procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start30 Nov 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recens Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arshad Khanani, MD, Principal investigator, Sierra Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732287
- Sponsor's protocol ID
- COOL-1.0
- Acronym
- COOL-1
- Status last verified
- May 2020
- First submitted
- 1 Nov 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Results of this study will be presented at a national meeting
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Ranging Study Evaluating the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL 1)
- ClinicalTrials.gov ID
- NCT03732287
- Acronym / sponsor ID
- COOL-1 / COOL-1.0
- Keywords
- intravitreal injection, anesthesia, macular degeneration, diabetic macular edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Recens Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.
Detailed description
Intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema. There is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. Current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia.
Recens Medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye This device cools to a temperature around -5 to -10 degrees Celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. The value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections.
This device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care.
This dose escalation study will test various temperatures and duration of temperatures to evaluate for safety as well as determine the optimal temperature for anesthesia during intravitreal injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection
| Arm | Type | Receives |
|---|---|---|
| -5 degrees Celsius for 10 seconds | Experimental | Device: Cooling Anesthesia |
| -5 degrees Celsius for 20 seconds | Experimental | Device: Cooling Anesthesia |
| -10 degrees Celsius for 10 seconds | Experimental | Device: Cooling Anesthesia |
| -10 degrees Celsius for 20 seconds | Experimental | Device: Cooling Anesthesia |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women > 18 years old at screening visit.
- Men and women who are undergoing intravitreal injections in either one eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle.
- Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit.
- Subject is willing and able to sign the study written informed consent form (ICF).
Key exclusion criteria (10 listed)
- History of presence of scleromalacia
- Preexisting conjunctival, episcleral or scleral defects
- Less than 18 years of age
- Unable to provide informed consent
- Has received less than 3 injections in the study eye
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 |
|---|---|---|
| Cooling AnesthesiaApplication of cooling anesthesia device prior to intravitreal injection | Device | -10 degrees Celsius for 10 seconds, -10 degrees Celsius for 20 seconds, -5 degrees Celsius for 10 seconds, -5 degrees Celsius for 20 seconds |
Primary outcome
Subjective Pain
Time frame: 24-48 hours after injection
Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.
Number of patients with treatment adverse events as measured by slit lamp examination
Time frame: 30 minutes after injection
Full slit lamp examination of anterior and posterior segment after intravitreal injection
2 secondary outcomes
Subject response to needle penetration
Time frame: Intraoperative (During injection)
Time to perform intravitreal injection
Time frame: Intraoperative (injection procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided. Results of this study will be presented at a national meeting
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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.
Arshad Khanani, MD principal investigator
Sierra Eye Associates
2 sites 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 Cooling Anesthesia in people with Anesthesia, Local and Intravitreal Injection, run by Recens Medical, Inc. at 2 sites 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 4 inclusion and 10 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Pain (time frame: 24-48 hours after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.