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Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01027611
Enrollment
120
Registered
2009-12-08
Start date
2009-10-31
Completion date
2009-12-31
Last updated
2010-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Effectiveness of topical pain medicine for control of pain associated with intravitreal injections, Eye discomfort

Brief summary

There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.

Detailed description

In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.

Interventions

DRUGproparacaine HCL 0.5%
DRUGproparacaine HCL 0.5% + 4% lidocaine solution
DRUG3.5% viscous lidocaine gel

Sponsors

Illinois Retina Associates
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients requiring intravitreal injection for treatment of eye disease

Exclusion criteria

* Eye infection * Retinal detachment * Age less than 18 years * Pregnant * Unable or unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frame
Injection experience gradeOutcome data is obtained approximately 10 seconds after conclusion of procedure

Secondary

MeasureTime frame
Pain grades for lid speculum, needle insertion, povidone iodine burning/stingingOutcome data is obtained approximately 10 seconds after conclusion of procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026