Long Term Safety of Cooling Anesthesia for Intravitreal Injection

NCT03956797 | Completed FDA Device

• 1 other identifier: COOL-2.0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Conditions

Anesthesia, Local; Intravitreal Injection; Macular Edema; Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema

Keywords

Intravitreal Injection; Anesthesia; Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Pain of Intravitreal Injection: VAS

  Pain of intravitreal injection as measured by 10-point visual analog scale (VAS) (0 meaning no pain, 10 meaning the most severe pain).

  Immediately after injection

• Incidence of Anesthesia-Related Adverse Events

  % of patients that experience cooling anesthesia device-related adverse events, as assessed by anterior segment and posterior segment examination.

  30 minutes after injection

Secondary Outcomes (4)

• Patient Movement During Intravitreal Injection

  During injection

• Time

  Time for entire intravitreal injection procedure

• Patient Anesthetic Preference

  24-48 hours after injection

• Pain of Intravitreal Injection (Follow-Up): VAS

  24-48 hours after injection

Study Arms (2)

-15 degrees Celsius for 10 seconds

EXPERIMENTAL

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 10 seconds.

Device: Recens Cooling Anesthesia Device

-15 degrees Celsius for 15 seconds

EXPERIMENTAL

Cooling anesthesia device applied to the eye at -15 degrees Celsius for 15 seconds.

Device: Recens Cooling Anesthesia Device

Interventions

Recens Cooling Anesthesia Device DEVICE

Application of cooling anesthesia device prior to intravitreal injection

-15 degrees Celsius for 10 seconds; -15 degrees Celsius for 15 seconds

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 other prescription drugs for dry eye.
• History of Endophthalmitis with intravitreal injection
• History of uveitis
• History of retinal detachment in either eye
• History of vitrectomy
• Subjects who received administration of cooling anesthesia as part of the COOL-1 study will not be excluded and are eligible to participate in this study.

Sponsors & Collaborators

• Recens Medical, Inc.: lead

Study Sites (2)

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Macular Edema; Macular Degeneration; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Arshad Khanani, MD

  Sierra Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 21, 2019
• Study Start: April 15, 2019
• Primary Completion: March 31, 2021
• Study Completion: April 2, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (2)