<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02263690</url>
  </required_header>
  <id_info>
    <org_study_id>RetinaC</org_study_id>
    <nct_id>NCT02263690</nct_id>
  </id_info>
  <brief_title>Comparison of Three Different Anesthetic Approaches for Intravitreal Injections</brief_title>
  <official_title>Comparison of Three Different Anesthetic Approaches for Intravitreal Injections: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Retina Clinic, Sao Paulo, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Retina Clinic, Sao Paulo, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups:&#xD;
      proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine&#xD;
      (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain&#xD;
      experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the&#xD;
      injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded&#xD;
      the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician&#xD;
      evaluated the patient's eye movement during intravitreal injection in three levels: none or&#xD;
      minimal (0), not compromising the injection (1), compromising the injection (2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, randomized, triple-armed trial compared the effectiveness of three&#xD;
      different anesthetic approaches for intravitreal injections. Were included 92 consecutive&#xD;
      patients scheduled to receive intravitreal injection of bevacizumab (Avastin, Genentech,&#xD;
      Inc.) in one eye, from June 2014 to September 2014, evaluated at at a single center - Retina&#xD;
      Clinic, Osasco, São Paulo, Brazil. The same ophthalmologist (CGA) administered both,&#xD;
      anesthetic and therapeutic, injections. A masked nurse collected patient assessment responses&#xD;
      and a masked statistician performed statistical analyses. The research followed the tenets of&#xD;
      the Declaration of Helsinki and was approved by the Committee of Ethics in Research. All&#xD;
      participants gave written informed consent prior to their participation.&#xD;
&#xD;
      Patients were randomized to 1 of 3 groups before injection: proparacaine 0.5% drops&#xD;
      (Anestalcon®, Alcon Lab. do Brasil Ltda, São Paulo, Brazil), (Group Drops), proparacaine plus&#xD;
      subconjunctival lidocaine 1% (Xylestesin®, Cristália, São Paulo, Brazil) (Group SC), or 2%&#xD;
      lidocaine gel (Xylestesin®, Cristália, São Paulo, Brazil) (Group Gel).&#xD;
&#xD;
      A standardized method was used to prepare the injection site and disinfect the skin using&#xD;
      povidone iodine 10%. Patients from groups Drops and SC received a drop of proparacaine 0.5%&#xD;
      before receiving a drop of povidone iodine 5%. For the patients from Group Gel, the gel was&#xD;
      placed on the eye before receiving the drop of povidone iodine 5%. Patients from Group Drops&#xD;
      received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%.&#xD;
      For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting&#xD;
      0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal&#xD;
      limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe. After 5 minutes of the&#xD;
      drop of povidone iodine 5%, sterile field and a lid speculum were placed. The injection site&#xD;
      was measured with calipers to be 3.5 mm or 4.0 mm posterior to the superotemporal limbus, for&#xD;
      pseudophakic and phakic eyes, respectively. A 30-gauge 1/2-inch needle was used to inject&#xD;
      0.05 ml of bevacizumab (Avastin, Genentech, Inc.). After the injection, mild pressure was&#xD;
      applied with a swabstick over the injection site to reduce vitreous reflux and&#xD;
      subconjunctival hemorrhage another a drop of povidone iodine 5% was applied.&#xD;
&#xD;
      Immediately following the injection, a nurse, who was masked to the treatment, explained the&#xD;
      100-mm visual analog scale (VAS) for pain (Figure 1) and questioned the patients' level of&#xD;
      pain perceived during the injection. This assessment was repeated 10 minutes, 1 hour, 6 hours&#xD;
      and 24 hours later, without visualization of their prior responses. Patients were also asked&#xD;
      to grade their overall experience with the injection procedure as Excellent (5), Very good&#xD;
      (4), Fair (3), Poor (2) or Awful (1). The physician evaluated the patients' eye movement&#xD;
      during intravitreal injection into three levels: none or minimal (0), not compromising the&#xD;
      injection (1), compromising the injection (2). Complications that occurred during or after&#xD;
      the procedures were also recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain experience and patient satisfaction after 3 different anesthetic approaches for intravitreal injections</measure>
    <time_frame>immediately after injection, 10 minutes, 1 hour, 6 hours and 24 hours later</time_frame>
    <description>Pain experience according the visual analogue scale (VAS), a scale of 0 to 10 (0 = no pain, 10 = worst pain ever).&#xD;
Patient satisfaction according the overall injection experience, graded by the patient as Excellent, Very Good, Fair, Poor, or Awful.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Group Drops</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>proparacaine 0.5% drops (Group Drops)&#xD;
Patients from group Drops received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%.&#xD;
Patients from Group Drops received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group SC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC)&#xD;
Patients from group SC received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%.&#xD;
For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting 0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine gel 2% on the eye (Group Gel)&#xD;
Patients from Group Gel received 1 mL of 2% lidocaine gel on the eye before receiving the drop of povidone iodine 5%.&#xD;
For the patients from Group Gel, 1 mL of 2% lidocaine gel was applied on the eye before receiving the drop of povidone iodine 5%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group Drops</intervention_name>
    <description>The patients in the group Drops received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. The patients in the group Drops received a second drop of proparacaine 0.5% 5 minutes after the drop of povidone iodide 5%</description>
    <arm_group_label>Group Drops</arm_group_label>
    <other_name>Proparacaine 0.5% drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group SC</intervention_name>
    <description>The patients in the group SC received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. In the patients in the group SC, a subconjunctival bleb of anesthesia was created by injecting 0,4 mL of lidocaine 1% into the subconjunctival space 4 mm posterior to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-mL syringe.</description>
    <arm_group_label>Group SC</arm_group_label>
    <other_name>Subconjunctival 1% Lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group gel</intervention_name>
    <description>For the patients in group gel, the gel was placed on the eye before receiving the peri-ocular drop of povidone iodide 5%.</description>
    <arm_group_label>Group Gel</arm_group_label>
    <other_name>Lidocaine 2% gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  Indications for injection included neovascular AMD, DME and cystoid macular edema&#xD;
             (CME) secondary to RVO.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous known allergic response to the topical anesthetics to be used.&#xD;
&#xD;
          -  Previous intravitreal injections of drugs other than anti-VEGF agents&#xD;
&#xD;
          -  Previous pars plana vitrectomy&#xD;
&#xD;
          -  Anterior segment conditions that could affect pain sensation, such as conjunctival&#xD;
             irritation, active conjunctivitis or keratitis or bullous keratopathy&#xD;
&#xD;
          -  Patients using systemic analgesic or sedative medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel C Andrade, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vitreo-retinal Fellow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Clinic</name>
      <address>
        <city>Osasco</city>
        <state>São Paulo</state>
        <zip>06010-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Aiello LP, Brucker AJ, Chang S, Cunningham ET Jr, D'Amico DJ, Flynn HW Jr, Grillone LR, Hutcherson S, Liebmann JM, O'Brien TP, Scott IU, Spaide RF, Ta C, Trese MT. Evolving guidelines for intravitreous injections. Retina. 2004 Oct;24(5 Suppl):S3-19. doi: 10.1097/00006982-200410001-00002.</citation>
    <PMID>15483476</PMID>
  </results_reference>
  <results_reference>
    <citation>Ulrich JN. Topical nepafenac after intravitreal injection: a prospective double-masked randomized controlled trial. Retina. 2014 Mar;34(3):509-11. doi: 10.1097/IAE.0b013e3182a0e611.</citation>
    <PMID>23928675</PMID>
  </results_reference>
  <results_reference>
    <citation>Brynskov T, Kemp H, Sorensen TL. No cases of endophthalmitis after 20,293 intravitreal injections in an operating room setting. Retina. 2014 May;34(5):951-7. doi: 10.1097/IAE.0000000000000071.</citation>
    <PMID>24317292</PMID>
  </results_reference>
  <results_reference>
    <citation>Nuzzi R, Tridico F. Local and systemic complications after intravitreal administration of anti-vascular endothelial growth factor agents in the treatment of different ocular diseases: a five-year retrospective study. Semin Ophthalmol. 2015 Mar;30(2):129-35. doi: 10.3109/08820538.2013.835833. Epub 2013 Oct 30.</citation>
    <PMID>24171832</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>19205490</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. doi: 10.1177/112067210601600509.</citation>
    <PMID>17061223</PMID>
  </results_reference>
  <results_reference>
    <citation>Bartfield JM, Holmes TJ, Raccio-Robak N. A comparison of proparacaine and tetracaine eye anesthetics. Acad Emerg Med. 1994 Jul-Aug;1(4):364-7. doi: 10.1111/j.1553-2712.1994.tb02646.x.</citation>
    <PMID>7614283</PMID>
  </results_reference>
  <results_reference>
    <citation>Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724.</citation>
    <PMID>21102369</PMID>
  </results_reference>
  <results_reference>
    <citation>Davis MJ, Pollack JS, Shott S. Comparison of topical anesthetics for intravitreal injections : a randomized clinical trial. Retina. 2012 Apr;32(4):701-5. doi: 10.1097/IAE.0b013e31822f27ca.</citation>
    <PMID>22282296</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>16340529</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>17056383</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>19898665</PMID>
  </results_reference>
  <results_reference>
    <citation>Boden JH, Myers ML, Lee T, Bushley DM, Torres MF. Effect of lidocaine gel on povidone-iodine antisepsis and microbial survival. J Cataract Refract Surg. 2008 Oct;34(10):1773-5. doi: 10.1016/j.jcrs.2008.05.056.</citation>
    <PMID>18812132</PMID>
  </results_reference>
  <results_reference>
    <citation>Inman ZD, Anderson NG. Incidence of endophthalmitis after intravitreal injection of antivascular endothelial growth factor medications using topical lidocaine gel anesthesia. Retina. 2011 Apr;31(4):669-72. doi: 10.1097/IAE.0b013e3181ef463d.</citation>
    <PMID>21178659</PMID>
  </results_reference>
  <results_reference>
    <citation>Charles S, Rosenfeld PJ, Gayer S. Medical consequences of stopping anticoagulant therapy before intraocular surgery or intravitreal injections. Retina. 2007 Sep;27(7):813-5. doi: 10.1097/IAE.0b013e318154b9f2. No abstract available.</citation>
    <PMID>17891002</PMID>
  </results_reference>
  <results_reference>
    <citation>Meyer CH, Callizo J, Mennel S, Kussin A. Perioperative management of anticoagulated patients undergoing repeated intravitreal injections. Arch Ophthalmol. 2007 Jul;125(7):994. doi: 10.1001/archopht.125.7.994. No abstract available.</citation>
    <PMID>17620596</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Retina Clinic, Sao Paulo, Brazil</investigator_affiliation>
    <investigator_full_name>Gabriel Costa de Andrade</investigator_full_name>
    <investigator_title>Gabriel Costa de Andrade</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02263690
org study id: RetinaC
nct id: NCT02263690
lead sponsor: 
has dmc: Yes
92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups:
      proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine
      (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain
      experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the
      injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded
      the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician
      evaluated the patient's eye movement during intravitreal injection in three levels: none or
      minimal (0), not compromising the injection (1), compromising the injection (2).
This prospective, randomized, triple-armed trial compared the effectiveness of three
      different anesthetic approaches for intravitreal injections. Were included 92 consecutive
      patients scheduled to receive intravitreal injection of bevacizumab (Avastin, Genentech,
      Inc.) in one eye, from June 2014 to September 2014, evaluated at at a single center - Retina
      Clinic, Osasco, São Paulo, Brazil. The same ophthalmologist (CGA) administered both,
      anesthetic and therapeutic, injections. A masked nurse collected patient assessment responses
      and a masked statistician performed statistical analyses. The research followed the tenets of
      the Declaration of Helsinki and was approved by the Committee of Ethics in Research. All
      participants gave written informed consent prior to their participation.

      Patients were randomized to 1 of 3 groups before injection: proparacaine 0.5% drops
      (Anestalcon®, Alcon Lab. do Brasil Ltda, São Paulo, Brazil), (Group Drops), proparacaine plus
      subconjunctival lidocaine 1% (Xylestesin®, Cristália, São Paulo, Brazil) (Group SC), or 2%
      lidocaine gel (Xylestesin®, Cristália, São Paulo, Brazil) (Group Gel).

      A standardized method was used to prepare the injection site and disinfect the skin using
      povidone iodine 10%. Patients from groups Drops and SC received a drop of proparacaine 0.5%
      before receiving a drop of povidone iodine 5%. For the patients from Group Gel, the gel was
      placed on the eye before receiving the drop of povidone iodine 5%. Patients from Group Drops
      received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%.
      For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting
      0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal
      limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe. After 5 minutes of the
      drop of povidone iodine 5%, sterile field and a lid speculum were placed. The injection site
      was measured with calipers to be 3.5 mm or 4.0 mm posterior to the superotemporal limbus, for
      pseudophakic and phakic eyes, respectively. A 30-gauge 1/2-inch needle was used to inject
      0.05 ml of bevacizumab (Avastin, Genentech, Inc.). After the injection, mild pressure was
      applied with a swabstick over the injection site to reduce vitreous reflux and
      subconjunctival hemorrhage another a drop of povidone iodine 5% was applied.

      Immediately following the injection, a nurse, who was masked to the treatment, explained the
      100-mm visual analog scale (VAS) for pain (Figure 1) and questioned the patients' level of
      pain perceived during the injection. This assessment was repeated 10 minutes, 1 hour, 6 hours
      and 24 hours later, without visualization of their prior responses. Patients were also asked
      to grade their overall experience with the injection procedure as Excellent (5), Very good
      (4), Fair (3), Poor (2) or Awful (1). The physician evaluated the patients' eye movement
      during intravitreal injection into three levels: none or minimal (0), not compromising the
      injection (1), compromising the injection (2). Complications that occurred during or after
      the procedures were also recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain experience and patient satisfaction after 3 different anesthetic approaches for intravitreal injections
time frame: immediately after injection, 10 minutes, 1 hour, 6 hours and 24 hours later
description: Pain experience according the visual analogue scale (VAS), a scale of 0 to 10 (0 = no pain, 10 = worst pain ever).
Patient satisfaction according the overall injection experience, graded by the patient as Excellent, Very Good, Fair, Poor, or Awful.
arm group label: Group Drops
arm group type: Active Comparator
description: proparacaine 0.5% drops (Group Drops)
Patients from group Drops received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%.
Patients from Group Drops received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%.
arm group label: Group SC
arm group type: Active Comparator
description: proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC)
Patients from group SC received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%.
For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting 0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe.
arm group label: Group Gel
arm group type: Active Comparator
description: Lidocaine gel 2% on the eye (Group Gel)
Patients from Group Gel received 1 mL of 2% lidocaine gel on the eye before receiving the drop of povidone iodine 5%.
For the patients from Group Gel, 1 mL of 2% lidocaine gel was applied on the eye before receiving the drop of povidone iodine 5%.
intervention type: Procedure
intervention name: Group Drops
description: The patients in the group Drops received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. The patients in the group Drops received a second drop of proparacaine 0.5% 5 minutes after the drop of povidone iodide 5%
arm group label: Group Drops
other name: Proparacaine 0.5% drops
intervention type: Procedure
intervention name: Group SC
description: The patients in the group SC received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. In the patients in the group SC, a subconjunctival bleb of anesthesia was created by injecting 0,4 mL of lidocaine 1% into the subconjunctival space 4 mm posterior to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-mL syringe.
arm group label: Group SC
other name: Subconjunctival 1% Lidocaine
intervention type: Procedure
intervention name: Group gel
description: For the patients in group gel, the gel was placed on the eye before receiving the peri-ocular drop of povidone iodide 5%.
arm group label: Group Gel
other name: Lidocaine 2% gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel C Andrade, M.D.
role: Principal Investigator
affiliation: Vitreo-retinal Fellow
facility: 
country: Brazil
citation: Aiello LP, Brucker AJ, Chang S, Cunningham ET Jr, D'Amico DJ, Flynn HW Jr, Grillone LR, Hutcherson S, Liebmann JM, O'Brien TP, Scott IU, Spaide RF, Ta C, Trese MT. Evolving guidelines for intravitreous injections. Retina. 2004 Oct;24(5 Suppl):S3-19. doi: 10.1097/00006982-200410001-00002.
PMID: 15483476
citation: Ulrich JN. Topical nepafenac after intravitreal injection: a prospective double-masked randomized controlled trial. Retina. 2014 Mar;34(3):509-11. doi: 10.1097/IAE.0b013e3182a0e611.
PMID: 23928675
citation: Brynskov T, Kemp H, Sorensen TL. No cases of endophthalmitis after 20,293 intravitreal injections in an operating room setting. Retina. 2014 May;34(5):951-7. doi: 10.1097/IAE.0000000000000071.
PMID: 24317292
citation: Nuzzi R, Tridico F. Local and systemic complications after intravitreal administration of anti-vascular endothelial growth factor agents in the treatment of different ocular diseases: a five-year retrospective study. Semin Ophthalmol. 2015 Mar;30(2):129-35. doi: 10.3109/08820538.2013.835833. Epub 2013 Oct 30.
PMID: 24171832
citation: 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.
PMID: 19205490
citation: Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. doi: 10.1177/112067210601600509.
PMID: 17061223
citation: Bartfield JM, Holmes TJ, Raccio-Robak N. A comparison of proparacaine and tetracaine eye anesthetics. Acad Emerg Med. 1994 Jul-Aug;1(4):364-7. doi: 10.1111/j.1553-2712.1994.tb02646.x.
PMID: 7614283
citation: Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for intravitreal injections. Retina. 2011 Mar;31(3):535-9. doi: 10.1097/IAE.0b013e3181eac724.
PMID: 21102369
citation: Davis MJ, Pollack JS, Shott S. Comparison of topical anesthetics for intravitreal injections : a randomized clinical trial. Retina. 2012 Apr;32(4):701-5. doi: 10.1097/IAE.0b013e31822f27ca.
PMID: 22282296
citation: 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.
PMID: 16340529
citation: 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.
PMID: 17056383
citation: 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.
PMID: 19898665
citation: Boden JH, Myers ML, Lee T, Bushley DM, Torres MF. Effect of lidocaine gel on povidone-iodine antisepsis and microbial survival. J Cataract Refract Surg. 2008 Oct;34(10):1773-5. doi: 10.1016/j.jcrs.2008.05.056.
PMID: 18812132
citation: Inman ZD, Anderson NG. Incidence of endophthalmitis after intravitreal injection of antivascular endothelial growth factor medications using topical lidocaine gel anesthesia. Retina. 2011 Apr;31(4):669-72. doi: 10.1097/IAE.0b013e3181ef463d.
PMID: 21178659
citation: Charles S, Rosenfeld PJ, Gayer S. Medical consequences of stopping anticoagulant therapy before intraocular surgery or intravitreal injections. Retina. 2007 Sep;27(7):813-5. doi: 10.1097/IAE.0b013e318154b9f2. No abstract available.
PMID: 17891002
citation: Meyer CH, Callizo J, Mennel S, Kussin A. Perioperative management of anticoagulated patients undergoing repeated intravitreal injections. Arch Ophthalmol. 2007 Jul;125(7):994. doi: 10.1001/archopht.125.7.994. No abstract available.
PMID: 17620596
responsible party type: Principal Investigator
investigator affiliation: Retina Clinic, Sao Paulo, Brazil
investigator full name: Gabriel Costa de Andrade
investigator title: Gabriel Costa de Andrade
mesh term: Lidocaine