At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 23 enrolled

Drug / intervention

Lidocaine +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02872012

NCT02872012Phase 2Completed

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Cryoanesthesia for Intravitreal Injections

University of Michigan·interventional·Posted Aug 18, 2016·Updated Sep 17, 2019

In Brief

A Phase 2 clinical trial evaluating Cryoanesthesia device and Lidocaine for Ocular Anesthesia. Completed, enrolled 23 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOcular Anesthesia

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartMar 2016

First PostedAug 2016

Primary CompletionJun 2018

TodayJul 2026

First PostedAug 18, 2016

Enrollment StartMar 1, 2016

Primary CompletionJun 1, 2018

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 9.9 years ago

Interventions

Cryoanesthesia devicedevice

The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.

Lidocainedrug

Lidocaine applied to the non-cryoanesthesia eye.