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| Name | Class |
|---|---|
| University of Miami | OTHER |
| Bascom Palmer Eye Institute | OTHER |
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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.
The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% lidocaine | Experimental | Eyes were anesthetized with 0.5% proparacaine and then with three cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of the injection inferotemporally to the limbus. Each participant was assigned to have this prep during one of the consecutive study visits if unilateral or in one eye if patient requires bilateral injections given the same day |
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| 3.5% ophthalmic lidocaine gel | Experimental | Eye was anesthetized with 0.5% proparacaine and then with 3.5% ophthalmic lidocaine gel applied to the surface of the eye. Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% lidocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied | immediately after injection, 1- hour later, and next day |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection. | immediately after injection, at 5, 10, 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ninel Gregori, MD | Miami VA Healthcare Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Veterans Affairs Medical Center | Miami | Florida | 33125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17056383 | Background | Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8. doi: 10.1016/j.ajo.2006.06.033. | |
| 17700338 | Background | Caudle LE, Williams KA, Pesudovs K. The Eye Sensation Scale: an ophthalmic pain severity measure. Optom Vis Sci. 2007 Aug;84(8):752-62. doi: 10.1097/OPX.0b013e31812f7690. |
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Patients were randomized upon recruitment and received the first anesthetic method on the day of recruitment, no wash out or transitional periods were necessary
Miami VA Medical Center retina injection clinic; patients needing frequent intravitreal injections of ranibizumab were approached and recruited between April 2010 and March 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral | Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other. |
| FG001 | Unilateral | Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection | Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied | all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day | Posted | Mean | Standard Deviation | units on a scale | immediately after injection, 1- hour later, and next day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4% Liquid Lidocaine Method | Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Gastrointestinal disorders | Systematic Assessment | death during hospitalization for general surgery |
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discomfort One hour after injection was assessed the next day via telephone and might be affected by recall bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ninel Gregori, MD | Miami Veterans Affairs Medical Center | 305-575-7000 | 3081 | ngregori@med.miami.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 3.5% ophthalmic lidocaine gel | Drug | 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. |
|
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| Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Presence of corneal staining after the injection:
Size of subconjunctival hemorrhage: in clock hours | within 10 minutes of the injection |
| 19686592 | Background | Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S. Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery. BMC Ophthalmol. 2009 Aug 17;9:7. doi: 10.1186/1471-2415-9-7. |
| 18831420 | Background | Busbee BG, Alam A, Reichel E. Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surg Lasers Imaging. 2008 Sep-Oct;39(5):386-90. doi: 10.3928/15428877-20080901-03. |
| 19898665 | Background | Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. doi: 10.2147/opth.s4935. Epub 2009 Nov 2. |
| 15313296 | Background | Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004 Aug;30(8):1716-20. doi: 10.1016/j.jcrs.2003.12.034. |
| 12511360 | Background | Bardocci A, Lofoco G, Perdicaro S, Ciucci F, Manna L. Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology. 2003 Jan;110(1):144-9. doi: 10.1016/s0161-6420(02)01562-2. |
| 19205490 | Background | Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8. doi: 10.3928/15428877-20090101-05. |
| 16340529 | Background | Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8. doi: 10.1097/00006982-200512000-00007. |
| 23632408 | Derived | Gregori NZ, Weiss MJ, Goldhardt R, Schiffman JC, Vega E, Mattis CA, Shi W, Kelley L, Hernandez V, Feuer WJ. Ocular decompression with cotton swabs lowers intraocular pressure elevation after intravitreal injection. J Glaucoma. 2014 Oct-Nov;23(8):508-12. doi: 10.1097/IJG.0b013e318294865c. |
| 22554019 | Derived | Gregori NZ, Weiss MJ, Goldhardt R, Schiffman JC, Vega E, Mattis CA, Shi W, Kelley L, Hernandez V, Feuer WJ. Randomized clinical trial of two anesthetic techniques for intravitreal injections: 4% liquid lidocaine on cotton swabs versus 3.5% lidocaine gel. Expert Opin Drug Deliv. 2012 Jul;9(7):735-41. doi: 10.1517/17425247.2012.685155. Epub 2012 May 3. |
| unable to survey by telephone |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | 3.5% Ophthalmic Lidocaine Gel | Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site. |
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| Secondary | Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg | intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection. | 48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively | Posted | Mean | Standard Deviation | mmHg | immediately after injection, at 5, 10, 15 minutes | eyes | Participants |
|
|
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| Secondary | Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage | Presence of corneal staining after the injection:
Size of subconjunctival hemorrhage: in clock hours | all eyes for which data were available were included | Posted | Mean | Standard Deviation | units on a scale | within 10 minutes of the injection | eyes | Participants |
|
|
|
| 1 |
| 53 |
| 0 |
| 53 |
| EG001 | 3.5% Ophthalmic Lidocaine Gel | Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site. | 1 | 53 | 0 | 53 |
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| Aniline Compounds |
| D000588 | Amines |