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Cooling Anesthesia for Intravitreal Injection

NCT03732287 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-27

No results posted yet for this study

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

Interventions

DEVICE

Cooling Anesthesia

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
2018-11-30
Primary Completion
2019-04-26
Completion
2019-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732287 on ClinicalTrials.gov