<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/NCT02215057</url>
  </required_header>
  <id_info>
    <org_study_id>1479</org_study_id>
    <nct_id>NCT02215057</nct_id>
  </id_info>
  <brief_title>Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral LIdocaine 1%</brief_title>
  <official_title>Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral Lidocaine 1% in Patients Undergoing Implantable Collamer Lens (ICL) Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as&#xD;
      most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were&#xD;
      performed deep into the orbit, but it is now accepted that peribulbar injections using&#xD;
      shorter needles are safer. In the last few years, continuing concern over the rare but&#xD;
      serious complications of sharp needle blocks has led to increasing interest in the use of&#xD;
      sub-Tenon's blocks utilizing a blunt cannula 1-5.&#xD;
&#xD;
      Even with the use of blunt canulae sub-Tenon's block, serious problems can still occur,&#xD;
      especially in myopic patients with large axial length. In phakic IOL surgery,topical&#xD;
      anesthesia has been used successfully for years. Topical anesthesia has several advantages&#xD;
      over regional infiltrative techniques, the foremost of which is the abolition of any risk of&#xD;
      inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient&#xD;
      satisfaction, but still there are some patients that experience intraoperative discomfort.&#xD;
&#xD;
      In this study we compared topical anesthesia alone with topical anesthesia plus intracameral&#xD;
      lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision&#xD;
      implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common&#xD;
      adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory&#xD;
      blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL&#xD;
      placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be&#xD;
      because of the direct action of lidocaine on the iris, which in turn causes muscle&#xD;
      relaxation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      were enrolled in this study after obtaining approval from the institutional ethical committee&#xD;
      and written patients consent. We estimated our sample size based on a method described by&#xD;
      Lerman. A sample size of 45 will detect a 20% difference between each group; this will give&#xD;
      an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we&#xD;
      decided to increase the number of patients in each group to 51.All patients were assessed and&#xD;
      only those who were deemed suitable for topical and intracameral lidocaine 1% were included&#xD;
      in the study.Very anxious patients were omitted from the study.&#xD;
&#xD;
      We are planning a study of matched sets of patients receiving the experimental and control&#xD;
      treatments with 1 matched control(s) per experimental subject. Prior data indicate that the&#xD;
      probability of a treatment failure among controls is 0.05 and the correlation coefficient for&#xD;
      exposure between matched experimental and control subjects are 0.1. If the true odds ratio&#xD;
      for failure in experimental subjects relative to control subjects is 0.1, we will need to&#xD;
      study 51 experimental subjects with 1 matched control(s) per experimental subject to be able&#xD;
      to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The&#xD;
      Type I error probability associated with this test of this null hypothesis is 0.3.&#xD;
&#xD;
      All the operations were done by one surgeon (SE).Patients were prepared for bilateral&#xD;
      ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and&#xD;
      Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the&#xD;
      start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a&#xD;
      peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial&#xD;
      blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic&#xD;
      drops .&#xD;
&#xD;
      Pain was estimated by the patient using a simple pain score: no pain =0; that does not&#xD;
      interfere with the surgical technique, discomfort=1; the surgical technique is performed with&#xD;
      difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was&#xD;
      done during different stages of surgery: lid retraction while inserting a speculum, tolerance&#xD;
      to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates,&#xD;
      irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical&#xD;
      technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium&#xD;
      hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding,&#xD;
      tucking of trailing footplates then side port incision and tucking of leading footplates,&#xD;
      MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PAIN</measure>
    <time_frame>15 MINUTES</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Other Iris and Ciliary Body Disorders</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%'</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical anesthesia</intervention_name>
    <description>topical anesthetic drops and Group 2</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>LOCAL ANESTHESIA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical anesthesia plus intracameral lidocaine 1%</intervention_name>
    <description>received topical anesthesia plus intracameral lidocaine 1%</description>
    <arm_group_label>Group 1</arm_group_label>
    <other_name>received topical anesthesia plus intracameral lidocaine 1%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any age&#xD;
&#xD;
          -  calm patient&#xD;
&#xD;
          -  agreed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co agulopathy anxious refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hassan M Ali, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magrabi Aseer ,KSA</name>
      <address>
        <city>Khamis Mushayt</city>
        <state>West</state>
        <zip>516</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 2, 2016</last_update_submitted>
  <last_update_submitted_qc>August 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hassan Mohamed Ali</investigator_full_name>
    <investigator_title>lecturer of anesthesia</investigator_title>
  </responsible_party>
  <keyword>topical anesthesia</keyword>
  <keyword>intracameral lidocaine</keyword>
  <keyword>implantable collamer lens</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics</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/NCT02215057
org study id: 1479
nct id: NCT02215057
lead sponsor: 
has dmc: Yes
General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as
      most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were
      performed deep into the orbit, but it is now accepted that peribulbar injections using
      shorter needles are safer. In the last few years, continuing concern over the rare but
      serious complications of sharp needle blocks has led to increasing interest in the use of
      sub-Tenon's blocks utilizing a blunt cannula 1-5.

      Even with the use of blunt canulae sub-Tenon's block, serious problems can still occur,
      especially in myopic patients with large axial length. In phakic IOL surgery,topical
      anesthesia has been used successfully for years. Topical anesthesia has several advantages
      over regional infiltrative techniques, the foremost of which is the abolition of any risk of
      inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient
      satisfaction, but still there are some patients that experience intraoperative discomfort.

      In this study we compared topical anesthesia alone with topical anesthesia plus intracameral
      lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision
      implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common
      adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory
      blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL
      placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be
      because of the direct action of lidocaine on the iris, which in turn causes muscle
      relaxation.
were enrolled in this study after obtaining approval from the institutional ethical committee
      and written patients consent. We estimated our sample size based on a method described by
      Lerman. A sample size of 45 will detect a 20% difference between each group; this will give
      an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we
      decided to increase the number of patients in each group to 51.All patients were assessed and
      only those who were deemed suitable for topical and intracameral lidocaine 1% were included
      in the study.Very anxious patients were omitted from the study.

      We are planning a study of matched sets of patients receiving the experimental and control
      treatments with 1 matched control(s) per experimental subject. Prior data indicate that the
      probability of a treatment failure among controls is 0.05 and the correlation coefficient for
      exposure between matched experimental and control subjects are 0.1. If the true odds ratio
      for failure in experimental subjects relative to control subjects is 0.1, we will need to
      study 51 experimental subjects with 1 matched control(s) per experimental subject to be able
      to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The
      Type I error probability associated with this test of this null hypothesis is 0.3.

      All the operations were done by one surgeon (SE).Patients were prepared for bilateral
      ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and
      Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the
      start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a
      peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial
      blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic
      drops .

      Pain was estimated by the patient using a simple pain score: no pain =0; that does not
      interfere with the surgical technique, discomfort=1; the surgical technique is performed with
      difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was
      done during different stages of surgery: lid retraction while inserting a speculum, tolerance
      to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates,
      irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical
      technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium
      hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding,
      tucking of trailing footplates then side port incision and tucking of leading footplates,
      MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PAIN
time frame: 15 MINUTES
arm group label: Group 2
arm group type: Experimental
description: topical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops
arm group label: Group 1
arm group type: Experimental
description: received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%'
intervention type: Drug
intervention name: topical anesthesia
description: topical anesthetic drops and Group 2
arm group label: Group 1
arm group label: Group 2
other name: LOCAL ANESTHESIA
intervention type: Drug
intervention name: topical anesthesia plus intracameral lidocaine 1%
description: received topical anesthesia plus intracameral lidocaine 1%
arm group label: Group 1
other name: received topical anesthesia plus intracameral lidocaine 1%
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hassan M Ali, Lecturer
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hassan Mohamed Ali
investigator title: lecturer of anesthesia
mesh term: Lidocaine
mesh term: Anesthetics