Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Lahey Clinic |
---|---|
Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00769392 |
This study is designed to compare four currently used types of anesthesia used for intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.
Condition | Intervention |
---|---|
Macular Degeneration |
Drug: Proparacaine Drug: Tetracaine Drug: Lidocaine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Proparacaine Drops
|
Drug: Proparacaine
Drops of Proparacaine on the eye, administered as described in the package insert
|
2: Active Comparator
Tetracaine Drops
|
Drug: Tetracaine
Drops of Tetracaine on the eye, administered as described in the package insert
|
3: Active Comparator
Lidocaine 4% soaked cotton sponge
|
Drug: Lidocaine
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
|
4: Active Comparator
Lidocaine 2% subconjunctival injection
|
Drug: Lidocaine
A subconjunctival injection of Lidocaine 2%
|
Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections.
Patients who have received prior injections and are scheduled to continue regular injections will be randomized to one of four types of anesthetic treatment for each of 4 treatment periods, so that each subject receives all four types of anesthesia over the course of the study, although the order will be different for each subject.
Following each procedure, patients will fill out a questionnaire, grading the discomfort of both the anesthesia and the injection(on separate 0-10 scales).
The anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine.
The subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study is the four injections or approximately 4 months and will be followed for up to 6 months.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregory R. Blaha, M.D., Ph.D. | 978-538-4400 | Gregory.R.Blaha@Lahey.org |
Contact: Avon P. Stewart | 978-538-4412 | Avon.P.Stewart@Lahey.org |
United States, Massachusetts | |
Lahey Clinic, Inc. | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Contact: Gregory R. Blaha, M.D., Ph.D. 781-744-8555 Gregory.R.Blaha@Lahey.org | |
Sub-Investigator: Elisha P. Tilton, M.D. | |
Sub-Investigator: Jeffrey L. Marx, M.D. | |
Sub-Investigator: Fina C. Barouch, M.D. | |
Lahey Clinic Northshore | Recruiting |
Peabody, Massachusetts, United States, 01960 | |
Contact: Avon P. Stewart 978-538-4412 Avon.P.Stewart@Lahey.org | |
Contact: Molly J. Concannon 978-538-4432 Molly.J.Concannon@Lahey.org | |
Sub-Investigator: Jeffrey L. Marx, M.D. | |
Sub-Investigator: Fina C. Barouch, M.D. | |
Sub-Investigator: Elisha P. Tilton, M.D. | |
Lahey Clinic Arlington | Recruiting |
Arlington, Massachusetts, United States, 02474 | |
Contact: Gregory R. Blaha, M.D., Ph.D. 781-744-7143 Gregory.R.Blaha@Lahey.org | |
Sub-Investigator: Fina C. Barouch, M.D. | |
Sub-Investigator: Elisha P. Tilton, M.D. | |
Sub-Investigator: Jeffrey L. Marx, M.D. |
Principal Investigator: | Gregory R. Blaha, M.D., Ph.D. | Lahey Clinic, Inc. |
Responsible Party: | Lahey Clinic, Inc. ( Gregory R. Blaha, M.D., Ph.D. ) |
Study ID Numbers: | 2008-076 |
Study First Received: | October 8, 2008 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00769392 History of Changes |
Health Authority: | United States: Institutional Review Board |
Macular Degeneration Intravitreal injections Eye anesthesia-Topical/subconjunctival Eye-surgical procedures Ophthalmologic anesthesia methods |
Eye Diseases Lidocaine Macular Degeneration Retinal Degeneration Anesthetics Central Nervous System Depressants Cardiovascular Agents |
Proxymetacaine Anesthetics, Local Tetracaine Peripheral Nervous System Agents Anti-Arrhythmia Agents Retinal Diseases |
Eye Diseases Physiological Effects of Drugs Lidocaine Macular Degeneration Retinal Degeneration Anesthetics Central Nervous System Depressants Cardiovascular Agents Proxymetacaine |
Anesthetics, Local Pharmacologic Actions Tetracaine Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Retinal Diseases |