PainNCT01087489

Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye

A study testing 4% lidocaine and 3.5% ophthalmic lidocaine gel in people with Pain, run by Miami VA Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: 4% lidocaine and 3.5% ophthalmic lidocaine gel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Jun 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
Informed consent
Age ≥ 18 years
Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
Able to understand and read English

Who cannot join

Pregnancy (positive pregnancy test)
Mental disability
Prisoners
Patients with fluctuating or impaired decision-making capacity
Inability to comply with study or follow-up procedures
Previous reaction to the same drug class

Trial locations and contacts

1 site in 1 country.

United States1 site

Miami Veterans Affairs Medical Center
Miami, Florida, 33125

Other trials in United States

About this study

Official title: Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection

Read the detailed description

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.

Conditions: Pain
Being tested: 4% lidocaine, 3.5% ophthalmic lidocaine gel
Keywords: pain, discomfort, anesthetic drugs, topical drug administration, injections, intraocular, lidocaine, intraocular pressure, keratopathy
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4% lidocaineDrug
Also called lidocaine
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.
3.5% ophthalmic lidocaine gelDrug
Also called Akten
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.

Study groups in NCT01087489
Study group	Role	What they receive
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 Receives: Drug: 4% lidocaine
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. Receives: Drug: 3.5% ophthalmic lidocaine gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: immediately after injection, 1- hour later, and next day

Secondary outcomes (2)

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.
Measured: immediately after injection, at 5, 10, 15 minutes
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage
Presence of corneal staining after the injection:
- Quadrants of fluorescein staining: 0 1 2 3 4
- Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion
Size of subconjunctival hemorrhage:
in clock hours
Measured: within 10 minutes of the injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2011

First posted16 Mar 2010 (estimated)
Study startApr 2010
Primary completionMar 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01087489
Sponsor's protocol ID: 00825
Status last verified: Nov 2012
First submitted: 15 Mar 2010
Last updated: 20 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17056383
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.
PubMed 17700338
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.
PubMed 19686592
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.
PubMed 18831420
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.
PubMed 19898665
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.
PubMed 15313296
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.
PubMed 12511360
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.
PubMed 19205490
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.
PubMed 16340529
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.
PubMed 23632408
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.
PubMed 22554019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
ClinicalTrials.gov ID: NCT01087489
Acronym / sponsor ID: 00825
Conditions: Pain
Keywords: pain, discomfort, anesthetic drugs, topical drug administration, injections, intraocular, lidocaine, intraocular pressure, keratopathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Miami VA Healthcare SystemUS federal agency
Collaborators: University of Miami, Bascom Palmer Eye Institute
Study start: Apr 2010
Primary completion: Mar 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 16 Mar 2010 (estimated)
Results: Posted 20 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
4% lidocaine	Experimental	Drug: 4% lidocaineEyes 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
3.5% ophthalmic lidocaine gel	Experimental	Drug: 3.5% ophthalmic lidocaine gelEye 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
Informed consent
Age ≥ 18 years
Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
Able to understand and read English

Key exclusion criteria (6 listed)

Pregnancy (positive pregnancy test)
Mental disability
Prisoners
Patients with fluctuating or impaired decision-making capacity
Inability to comply with study or follow-up procedures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
4% lidocaineAlso: lidocaineThe 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.	Drug	4% lidocaine
3.5% ophthalmic lidocaine gelAlso: AktenThe 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.	Drug	3.5% ophthalmic lidocaine gel

Primary outcome

Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection
Time frame: immediately after injection, 1- hour later, and next day
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

2 secondary outcomes

Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg
Time frame: immediately after injection, at 5, 10, 15 minutes
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage
Time frame: within 10 minutes of the injection

Results and safety

Results posted to the registry on 20 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bilateral	19	19
Unilateral	34	31

Primary outcome: Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection

Time frame: immediately after injection, 1- hour later, and next day. Mean (Standard Deviation). Unit: units on a scale

Measure	4% Liquid Lidocaine Method n = 50	3.5% Ophthalmic Lidocaine Gel n = 50
Discomfort during anesthetic preparation	2.1 (1.1)	2.09 (0.8)
Discomfort during needle penetration	1.7 (0.9)	2.0 (0.9)
Satisfaction with entire prep and injection	4.3 (1.0)	4.5 (0.8)
Discomfort 1 h after injection	2.4 (1.0)	2.1 (1.1)
Discomfort day after injection	1.8 (0.8)	1.6 (0.8)
Next day satisfaction with injection	4.3 (1.0)	4.3 (0.9)

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4% Liquid Lidocaine Method	1 of 53 (1.9%)	0 of 53 (0%)	Not reported
3.5% Ophthalmic Lidocaine Gel	1 of 53 (1.9%)	0 of 53 (0%)	Not reported

Limitations and caveats (from the sponsor): discomfort One hour after injection was assessed the next day via telephone and might be affected by recall bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17056383Friedman 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.
Background: PubMed 17700338Caudle 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.
Background: PubMed 19686592Chalam 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.
Background: PubMed 18831420Busbee 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.
Background: PubMed 19898665Page 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.
Background: PubMed 15313296Soliman 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.
Background: PubMed 12511360Bardocci 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.
Background: PubMed 19205490Cintra 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.
Background: PubMed 16340529Kozak 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.
Derived from this study: PubMed 23632408Gregori 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.
Derived from this study: PubMed 22554019Gregori 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ninel Gregori, MD principal investigator

Miami VA Healthcare Systems

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 4% lidocaine and 3.5% ophthalmic lidocaine gel in people with Pain, run by Miami VA Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection (time frame: immediately after injection, 1- hour later, and next day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087489, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.