CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
4% lidocaine +1 moredrug
Likely dose
Not stated in record
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Search/NCT01087489
NCT01087489N/ACompleted

Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection

Miami VA Healthcare System·interventional·Posted Mar 16, 2010·Updated Nov 20, 2012

In Brief

A clinical study evaluating 4% lidocaine and 3.5% ophthalmic lidocaine gel for Pain. Completed, enrolled 53 participants across 1 site.

Detailed Summary

Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2010
Enrollment StartApr 1, 2010
Primary CompletionMar 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.3 years ago

Interventions

4% lidocainedrug

The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant.

3.5% ophthalmic lidocaine geldrug

The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops.