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NCT01640171 · ClinicalTrials.gov registry record · NA
Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival
A NA study, sponsored by Retina Vitreous Associates of Florida.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT01640171: Completed NA study, sponsored by Retina Vitreous Associates of Florida.
NCT01640171 is a NA study that has completed, run by Retina Vitreous Associates of Florida. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640171, a NA study, has completed, sponsored by Retina Vitreous Associates of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: * Topical anesthetic drop: 21.48% * Topical viscous anesthetic: 23.33% * Topical anesthetic \& soaked cotton-tip or pledget: 29.79% * Subconjunctival injection of anesthetic: 24.02% * Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).
Primary Outcome
Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.
Interventions
- PROCEDURE Xylocaine 2% Injectable Anesthetic
- DRUG Proparacaine Hydrochloride 0.5% Drop
- DRUG Tetravisc 0.5% Gel
- DRUG Acuvail
- DRUG Intra-vitreal Anti-VEGF Drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT01640171 record still lists
NCT01640171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Xylocaine 2% Injectable Anesthetic is the first listed.
NCT01640171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01640171 about?
NCT01640171 is a clinical study titled "Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival". Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8...
What is the current status of trial NCT01640171?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01640171?
The interventions under investigation include: Xylocaine 2% Injectable Anesthetic (PROCEDURE), Proparacaine Hydrochloride 0.5% Drop (DRUG), Tetravisc 0.5% Gel (DRUG), Acuvail (DRUG), Intra-vitreal Anti-VEGF Drug (DRUG).
Who is sponsoring clinical trial NCT01640171?
This trial is sponsored by Retina Vitreous Associates of Florida, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01640171's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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