Cooling Anesthesia for Intravitreal Injection

NCT03732287 | Completed Phase 1 FDA Device

• 1 other identifier: COOL-1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

intravitreal injection; anesthesia; macular degeneration; diabetic macular edema

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  30 minutes after injection

Secondary Outcomes (2)

• Subject response to needle penetration

  Intraoperative (During injection)

• Time to perform intravitreal injection

  Intraoperative (injection procedure)

Study Arms (4)

-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

Interventions

Cooling Anesthesia DEVICE

Application of cooling anesthesia device prior to intravitreal injection

-10 degrees Celsius for 10 seconds; -10 degrees Celsius for 20 seconds; -5 degrees Celsius for 10 seconds; -5 degrees Celsius for 20 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 Xiidra drops.
• History of Endophthalmitis with intravitreal injection
• History of uveitis
• History of retinal detachment in either eye
• History of vitrectomy

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 Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Arshad Khanani, MD

  Sierra Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 6, 2018
• Study Start: November 30, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

US (2)