Long Term Safety of Cooling Anesthesia for Intravitreal Injection
NCT03956797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-08-31
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
Interventions
- DEVICE
-
Recens Cooling Anesthesia Device
Application of cooling anesthesia device prior to intravitreal injection
Sponsors & Collaborators
-
Recens Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Arshad Khanani, MD · Sierra Eye Associates
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-15
- Primary Completion
- 2021-03-31
- Completion
- 2021-04-02
- FDA Device
- Yes
Countries
- United States
Study Locations
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