At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 enrolled
Drug / intervention
Recens Cooling Anesthesia Devicedevice
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.
Long Term Evaluation of the Safety and Efficacy of Cooling Anesthesia for Local Anesthesia During Intravitreal Injection (COOL-2)
In Brief
A clinical study evaluating Recens Cooling Anesthesia Device for Anesthesia, Local and 5 related conditions. Completed, enrolled 80 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, Local, Intravitreal Injection, Macular Edema, Macular Degeneration, Diabetic Retinopathy, Diabetic Macular Edema
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedMay 21, 2019
Enrollment StartApr 15, 2019
Primary CompletionMar 31, 2021
Study CompletionApr 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.1 years ago
Interventions
Recens Cooling Anesthesia Devicedevice
Application of cooling anesthesia device prior to intravitreal injection