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NCT03732287 · ClinicalTrials.gov registry record · Phase 1
Cooling Anesthesia for Intravitreal Injection
A Phase 1 study of Diabetic Macular Edema and Macular Degeneration, sponsored by Recens Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT03732287: Completed Phase 1 study of Diabetic Macular Edema and Macular Degeneration, sponsored by Recens Medical.
NCT03732287 is a Phase 1 study of Diabetic Macular Edema and Macular Degeneration that has completed, run by Recens Medical. The registered enrollment target is 40 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03732287, a Phase 1 study of Diabetic Macular Edema and Macular Degeneration, has completed, sponsored by Recens Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Pain as measured by the visual analogue scale (VAS). This was used in the previously presented SOLAR study (Clinical trials.gov, NCT01926977). Total range is 0-10, with 0 being no pain, and 10 being unbearable pain.
Conditions Studied
Interventions
- DEVICE Cooling Anesthesia
Study Locations (2)
Nevada
- Sierra Eye Associates - Reno
Texas
- Retina Consultants of Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 1 |
What the finished NCT03732287 record still lists
NCT03732287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Cooling Anesthesia is the first listed.
NCT03732287 reports a single indexed study location in Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT03732287 about?
NCT03732287 is a clinical study titled "Cooling Anesthesia for Intravitreal Injection". 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 intrav...
What is the current status of trial NCT03732287?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-11-30. Estimated completion is 2019-04-26.
What conditions does trial NCT03732287 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Macular Degeneration, Anesthesia, Local, Intravitreal Injection.
What interventions are being tested in trial NCT03732287?
The interventions under investigation include: Cooling Anesthesia (DEVICE).
Who is sponsoring clinical trial NCT03732287?
This trial is sponsored by Recens Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03732287 being conducted?
This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03732287's enrollment target sits among peer trials
40 40th of 63 higher than 23 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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