Phase 2 N=23 Randomized Supportive Care

Cryoanesthesia for Intravitreal Injections

Ocular Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02872012 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Subjective Injection Pain — 7.0; 3.1; 3.0; 1.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cryoanesthesia device (Device); Lidocaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Injection Pain	7.0; 3.1; 3.0; 1.8; 2.4; 2.3	—

Summary

The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the surface of the eye immediately prior to intraocular injections. The investigators plan to carry out a pilot study to collect preliminary data on the effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal injections (IVT).

Eligibility Criteria

Inclusion Criteria

Bilateral macular disease due to either exudative macular degeneration or diabetic retinopathy requiring bilateral intravitreal injections
Have had at least one prior intravitreal injection
Able to give informed consent

Exclusion Criteria

Unilateral disease
Unable to provide consent
Preexisting conjunctival, episcleral or scleral defects or disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02872012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.