<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/NCT02196441</url>
  </required_header>
  <id_info>
    <org_study_id>1234656</org_study_id>
    <nct_id>NCT02196441</nct_id>
  </id_info>
  <brief_title>Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia Procedure</brief_title>
  <official_title>Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia in Patients Undergoing Implantable Contact Lens 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 anaesthesia now a days is not the first choice in phakic intra ocular lens surgery&#xD;
      (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease&#xD;
      the length of hospital stay and decreasing the costs direct the interest to the regional&#xD;
      anaesthesia By the time the traditional retro and peribulbar injections recede to a newer&#xD;
      techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to&#xD;
      the more safety profile Even though, still serious problems can occur specially in patients&#xD;
      with long axial length.&#xD;
&#xD;
      Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took&#xD;
      over with promising and successful results, decreasing length of hospital stay and increasing&#xD;
      patient satisfaction and fewer margins of complications.&#xD;
&#xD;
      In this study the investigators compared topical anaesthesia alone with DTFNBA in patients&#xD;
      undergoing posterior chamber phakic IOL surgery (Visian ICL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      102 patients scheduled for elective ICL/TICL implantation surgery were enrolled in this study&#xD;
      after obtaining approval from the institutional ethical committee and written patients&#xD;
      consent. the investigators are planning a study of matched sets of patients receiving the&#xD;
      case and control treatments with 1 matched control(s) per experimental subject. Prior data&#xD;
      indicate that the probability of a treatment failure among controls is 0.05 and the&#xD;
      correlation coefficient for exposure between matched experimental and control subjects is&#xD;
      0.1. The true odds ratio for failure in experimental subjects relative to control subjects is&#xD;
      0.1, so the investigators needed to study 51 experimental subjects with 1 matched control(s)&#xD;
      per experimental subject to be able to reject the null hypothesis that this odds ratio equals&#xD;
      1 with probability (power) 0.7. The Type I error probability associated with this test of&#xD;
      this null hypothesis is 0.3.&#xD;
&#xD;
      All patients were assessed and only those cooperative understanding patients who were deemed&#xD;
      suitable for topical and DTFNBA were included in the study. Very anxious patients were&#xD;
      omitted from the study.&#xD;
&#xD;
      All the operations were done by one surgeon . Patients were prepared for bilateral&#xD;
      implantable contact lens/toric implantable contact lens( ICL/TICL) procedure on the same day.&#xD;
&#xD;
      Group I (1 eye) received topical anaesthetic drops and Group 2 (the second eye) received&#xD;
      DTFNBA. Before giving the anaesthetics, a peripheral vein was cannulated and heart rate,&#xD;
      oxygen saturation and non-invasive arterial blood pressure were monitored.&#xD;
&#xD;
      Topical anaesthesia was done with 2% tetracaine local anaesthetic drops and DTFNBA was&#xD;
      performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the&#xD;
      conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic&#xD;
      drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by&#xD;
      grasping the limbus with Castroviejo 0.12 tissue forceps.&#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&#xD;
      was done during different stages of surgery: lid retraction while inserting a speculum,&#xD;
      tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of&#xD;
      footplates, irrigation aspiration (I/A )of viscoelastic, peripheral iridectomy.&#xD;
&#xD;
      The surgical technique was performed through a clear corneal 3.2 mm tunnel incision, followed&#xD;
      by sodium hyalurounate injection, ICL implantation and unfolding, tucking of trailing&#xD;
      footplates then side port incision and tucking of leading footplates, myostat injection, then&#xD;
      peripheral iridectomy . The total operative time was recorded for every case. If the pain&#xD;
      score was 0 or 1, no further management was required but if the pain score was 2 at any&#xD;
      stage, 1% preservative free lidocaine was injected intracamerally. Parametric data were&#xD;
      analyzed using Students t-test; non parametric data were compared using the Chi-square test.&#xD;
      A P value of &lt;0.05 was considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">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>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of pain free surgery and Tolerability</measure>
    <time_frame>during the surgical procedure, 15 minutes</time_frame>
    <description>the patient will be examined for optimum pain free condition (anesthesia)that allow the surgeon to proceed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>one hour post operative</time_frame>
    <description>Patient satisfaction concerning the procedure using a 2-point scale (1=satisfied, I would want the same anaesthesia/analgesia method for the next surgery, 2=unsatisfied, I would want a different anaesthesia/ analgesia method for the next surgery)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Local Anesthesia</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% bupivacaine Deep topical fornix nerve block anaesthesia (DTFNB)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% tetracaine local anaesthetic drops</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% tetracaine local anaesthetic drops</intervention_name>
    <description>topical anaesthetic drops</description>
    <arm_group_label>Group 1</arm_group_label>
    <other_name>topical anaesthetic drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% bupivacaine</intervention_name>
    <description>was performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by grasping the limbus with Castroviejo 0.12 tissue forceps.</description>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Deep topical fornix nerve block anaesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cooperative understanding patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Very anxious patients&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>
  <overall_contact>
    <last_name>Hassan M ALi, Lecturer</last_name>
    <phone>+201001733687</phone>
    <email>hassan364@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Magrabi Aseer ,KSA</name>
      <address>
        <city>Khamis Mushayt</city>
        <state>West</state>
        <zip>516</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <contact>
      <last_name>Hassan M Ali, lecturer</last_name>
      <phone>+201001733687</phone>
      <email>hassan364@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Sherif Eissa, Consultant</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</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>deep topical fornix nerve block</keyword>
  <keyword>topical anesthesia</keyword>
  <keyword>implantable contact lens procedure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Tetracaine</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/NCT02196441
org study id: 1234656
nct id: NCT02196441
lead sponsor: 
has dmc: Yes
General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery
      (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease
      the length of hospital stay and decreasing the costs direct the interest to the regional
      anaesthesia By the time the traditional retro and peribulbar injections recede to a newer
      techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to
      the more safety profile Even though, still serious problems can occur specially in patients
      with long axial length.

      Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took
      over with promising and successful results, decreasing length of hospital stay and increasing
      patient satisfaction and fewer margins of complications.

      In this study the investigators compared topical anaesthesia alone with DTFNBA in patients
      undergoing posterior chamber phakic IOL surgery (Visian ICL).
102 patients scheduled for elective ICL/TICL implantation surgery were enrolled in this study
      after obtaining approval from the institutional ethical committee and written patients
      consent. the investigators are planning a study of matched sets of patients receiving the
      case 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 is
      0.1. The true odds ratio for failure in experimental subjects relative to control subjects is
      0.1, so the investigators needed 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 patients were assessed and only those cooperative understanding patients who were deemed
      suitable for topical and DTFNBA were included in the study. Very anxious patients were
      omitted from the study.

      All the operations were done by one surgeon . Patients were prepared for bilateral
      implantable contact lens/toric implantable contact lens( ICL/TICL) procedure on the same day.

      Group I (1 eye) received topical anaesthetic drops and Group 2 (the second eye) received
      DTFNBA. Before giving the anaesthetics, a peripheral vein was cannulated and heart rate,
      oxygen saturation and non-invasive arterial blood pressure were monitored.

      Topical anaesthesia was done with 2% tetracaine local anaesthetic drops and DTFNBA was
      performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the
      conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic
      drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by
      grasping the limbus with Castroviejo 0.12 tissue forceps.

      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 aspiration (I/A )of viscoelastic, peripheral iridectomy.

      The surgical technique was performed through a clear corneal 3.2 mm tunnel incision, followed
      by sodium hyalurounate injection, ICL implantation and unfolding, tucking of trailing
      footplates then side port incision and tucking of leading footplates, myostat injection, then
      peripheral iridectomy . The total operative time was recorded for every case. If the pain
      score was 0 or 1, no further management was required but if the pain score was 2 at any
      stage, 1% preservative free lidocaine was injected intracamerally. Parametric data were
      analyzed using Students t-test; non parametric data were compared using the Chi-square test.
      A P value of <0.05 was considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Measure of pain free surgery and Tolerability
time frame: during the surgical procedure, 15 minutes
description: the patient will be examined for optimum pain free condition (anesthesia)that allow the surgeon to proceed
measure: patient satisfaction
time frame: one hour post operative
description: Patient satisfaction concerning the procedure using a 2-point scale (1=satisfied, I would want the same anaesthesia/analgesia method for the next surgery, 2=unsatisfied, I would want a different anaesthesia/ analgesia method for the next surgery)
arm group label: Group 2
arm group type: Experimental
description: 0.5% bupivacaine Deep topical fornix nerve block anaesthesia (DTFNB)
arm group label: Group 1
arm group type: Experimental
description: 2% tetracaine local anaesthetic drops
intervention type: Drug
intervention name: 2% tetracaine local anaesthetic drops
description: topical anaesthetic drops
arm group label: Group 1
other name: topical anaesthetic drops
intervention type: Drug
intervention name: 0.5% bupivacaine
description: was performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by grasping the limbus with Castroviejo 0.12 tissue forceps.
arm group label: Group 2
other name: Deep topical fornix nerve block anaesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hassan M Ali, Lecturer
role: Principal Investigator
affiliation: Cairo University
last name: Hassan M ALi, Lecturer
phone: +201001733687
email: hassan364@hotmail.com
facility: 
contact: 
investigator: 
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: Bupivacaine
mesh term: Anesthetics, Local
mesh term: Tetracaine
mesh term: Anesthetics