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OpenTrials
Completed

NCT Number: NCT01027611

Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Illinois Retina Associates

Joliet, Illinois, 60435, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proparacaine HCL 0.5%

Drug

proparacaine HCL 0.5% + 4% lidocaine solution

Drug

3.5% viscous lidocaine gel

Drug

Primary outcomes

  1. Injection experience "grade"

    Time frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure

Secondary outcomes

  1. Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging

    Time frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure

Sponsors and collaborators

Lead sponsor

Illinois Retina Associates

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2009
Registry last updated
May 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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