Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
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ClinicalTrials.gov Identifier: NCT01027611 |
Recruitment Status :
Completed
First Posted : December 8, 2009
Last Update Posted : May 4, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: proparacaine HCL 0.5% Drug: proparacaine HCL 0.5% + 4% lidocaine solution Drug: 3.5% viscous lidocaine gel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: proparacaine HCL 0.5% |
Drug: proparacaine HCL 0.5% |
Experimental: proparacaine + lidocaine |
Drug: proparacaine HCL 0.5% + 4% lidocaine solution |
Experimental: lidocaine gel |
Drug: 3.5% viscous lidocaine gel |
- Injection experience "grade" [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ]
- Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027611
United States, Illinois | |
Illinois Retina Associates | |
Joliet, Illinois, United States, 60435 |
Study Chair: | John S. Pollack, MD | Illinois Retina Associates |
Responsible Party: | John S. Pollack, M.D., Illinois Retina Associates |
ClinicalTrials.gov Identifier: | NCT01027611 |
Other Study ID Numbers: |
jsp-001 |
First Posted: | December 8, 2009 Key Record Dates |
Last Update Posted: | May 4, 2010 |
Last Verified: | December 2009 |
Effectiveness of topical pain medicine for control of pain associated with intravitreal injections Eye discomfort |
Lidocaine Proxymetacaine Propoxycaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |