xml: <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/NCT05978687</url>
    </required_header>
    <id_info>
      <org_study_id>23149_Pterygium</org_study_id>
      <nct_id>NCT05978687</nct_id>
    </id_info>
    <brief_title>The Use of Lidocain Gel Versus Subconjunctival Xylocain Injection in Pterygium Excision</brief_title>
    <acronym>LIDPTER</acronym>
    <official_title>The Use of Lidocain Ophtesic Gel Versus Subconjunctival Xylocain Injection in Pterygium Excision</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vrije Universiteit Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vrije Universiteit Brussel</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an&#xD;
        uncomfortable and painful step in the procedure. While already being studied in other&#xD;
        ophthalmic procedures such as glaucoma surgery (7), application of topical lidocaine gel is&#xD;
        likely to minimize pain. The gel has a longer surface contact time due to its consistency,&#xD;
        providing not only a longer anesthetic effect, but protecting the corneal surface against&#xD;
        desiccation, when compared to eye drops.&#xD;
  &#xD;
        The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic&#xD;
        in pterygium excision as subconjunctival injection, while providing more comfort during&#xD;
        surgery and less corneal dryness afterwards.&#xD;
  &#xD;
        Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine&#xD;
        gel to subconjunctival injection of xylocain 2% solution with 0.125 epinephrine in pterygium&#xD;
        surgery:&#xD;
  &#xD;
          -  Compare the patients pain during and after surgery&#xD;
  &#xD;
          -  Compare corneal dryness after surgery.&#xD;
  &#xD;
          -  Evaluate possible secondary events&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pterygia are known as fibrovascular degenerations in the outer layer of the eye. Usually,&#xD;
        they cross the limbus onto the cornea. they develop over time and can cause symptoms such as&#xD;
        redness, itching, irritation and decreased vision. In severe cases, pterygiacan provoke&#xD;
        binocular diplopia due to contraction of the Tenon's capsule. Risk factors are age, UV&#xD;
        exposure and male gender.&#xD;
  &#xD;
        Rezvan F. et al conducted a meta-analysis to study the prevalance of pterygia in the world.&#xD;
        Their prevalence is estimated at 12% in the worldwide population, being higher in subtropical&#xD;
        regions. They occur slightly more in men, 13% versus 12%, when compared to women. The highest&#xD;
        prevalence is seen in patients over 80 years old (up to 19.5%).&#xD;
  &#xD;
        The exact mechanism of pathogenesis is not clear. A pterygium consists of degenerated&#xD;
        collagen tissue. Several previous studies have already proven the role of anti-apoptotic&#xD;
        proteins such as p53, a tumor suppressor protein. Its expression is elevated when compared to&#xD;
        normal conjunctival tissue. UV exposure is the most important risk factor. This theory is&#xD;
        supported by histopathologic actinic changes, similar to actinic keratosis, seen in pterygia.&#xD;
  &#xD;
        First line treatment for pterygia are conservative measures, like lubricants and sunglasses&#xD;
        to protect against additional harmful UV radiation. Yet, these measures are only symptomatic&#xD;
        and will not eliminate the cause. Surgery is regarded as an ideal solution in patients who&#xD;
        would like a definitive improvement of esthetic and visual problems. Several surgery&#xD;
        techniques are already known, but the most common is closure of the excised pterygium with a&#xD;
        conjunctival auto graft. In this technique, conjunctiva from the superotemporal limbal part&#xD;
        of the patient's eye is used to cover the excised pterygium area. A systematic review&#xD;
        compared the risk of recurrence of this technique to the use of an amniotic membrane and&#xD;
        concluded that the risk of recurrence was 46% percent less in the first group.&#xD;
  &#xD;
        These days, subconjunctival injection of xylocain 2% solution with 0.125 epinephrine is the&#xD;
        most used anesthesia technique. The anesthesia is infero- or superotemporal administered&#xD;
        5-8mm from the limbus. While giving excellent anesthetic result, the pain and anxiety caused&#xD;
        by this injection implied the need for new techniques. In chalazion and cataract surgery,&#xD;
        lidocaine gel is already confirmed to have a sufficient anesthetic effect on patients while&#xD;
        the amount of pain and anxiety during administration was decreased. In pterygium surgery,&#xD;
        both and proves that pain was less during both anesthesia administration and&#xD;
        post-operatively. Now that Ophtesic lidocaine gel is also on-label for pterygium excision, in&#xD;
        many centers the gel is used as standard of care.&#xD;
  &#xD;
        With Oksuz et al. (3) already having investigated the efficacy of lidocaine gel in pterygium&#xD;
        surgery, there might be more advantages yet to be investigated. For example, the lidocaine&#xD;
        gel has the advantage of having a viscous consistency. This allows the gel to protect the eye&#xD;
        from desiccating during surgery. Our primary goal in this study is to compare the ef-fect on&#xD;
        dryness and irritation in patients after pterygium surgery with both methods of an-aesthesia&#xD;
        by using the OSDI score questionnaire and the Oxford Dry Scale. In addition to equal&#xD;
        anaesthetic effect, this could push the standard of care in favour of the lidocaine gel.&#xD;
  &#xD;
        In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an&#xD;
        uncomfortable and painful step in the procedure. Already proved to be equal, the gel has a&#xD;
        longer surface contact time due to its consistency, providing not only a longer anesthetic&#xD;
        effect, but protecting the corneal surface against desiccation, when compared to eye drops.&#xD;
        Nowadays, it is already considered as the standard of care.&#xD;
  &#xD;
        The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic&#xD;
        in pterygium excision as subconjunctival injection, while providing more comfort during&#xD;
        surgery and less corneal dryness afterwards.&#xD;
  &#xD;
        Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine&#xD;
        gel to subconjunctival injection of xylocain 2% solution with 0.125 epinephrine in pterygium&#xD;
        surgery:&#xD;
  &#xD;
          -  Compare the patients pain during and after surgery&#xD;
  &#xD;
          -  Compare corneal dryness after surgery.&#xD;
  &#xD;
          -  Evaluate possible secondary events (e.g. enophtalmitis or non-adherence of the graft)&#xD;
  &#xD;
        Procedure Anesthesia In group A, all patients will receive topical Povidone- Iodine and 2%&#xD;
        lidocaine gel prior to surgery. In group B, all patients will receive Povidone- Iodine and a&#xD;
        subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine&#xD;
        will be injected with a 27-gauge needle. When asked for, patients will receive additional&#xD;
        topical 1% lidocaine eye drops.&#xD;
  &#xD;
        Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a&#xD;
        Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is&#xD;
        removed by blunt dissection. The subconjunctival tissue under the body of the lesion is&#xD;
        removed. The conjunctival graft is separated from the Tenon's capsule for harvest by&#xD;
        ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The&#xD;
        autograft is excised from the superior temporal side. Hereafter, the graft is secured to the&#xD;
        recipient bed with sutures. The traction suture is removed. All operations are executed by&#xD;
        the same surgeon.&#xD;
  &#xD;
        Following outcomes will be assessed:&#xD;
  &#xD;
        • Pain The investigators will monitor pain assessment with the Visual Analogue Pain Scale.&#xD;
        Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).&#xD;
        The assessment is done intra- and post- operatively by a nurse of the department. During both&#xD;
        assessments, the surgeon will leave the operating room.&#xD;
  &#xD;
        Pain will be monitored at following moments:&#xD;
  &#xD;
          -  Initial administration of anesthesia&#xD;
  &#xD;
          -  At incision&#xD;
  &#xD;
          -  Within 5 minutes after surgery&#xD;
  &#xD;
          -  Day one post-operative consult&#xD;
  &#xD;
               -  Dryness The dryness is assessed in two manners. The Oxford Dry Eye Scale (11)&#xD;
                  (Figure two) will be handled as an objective tool to grade dryness. The Ocular&#xD;
                  Surface Disease Index OSDI (12) (Figure three, four and five) is a subjective&#xD;
                  manner of assessing dryness. The questionnaire will be available in English, Dutch&#xD;
                  and French.&#xD;
  &#xD;
        At following moments the dryness will be monitored:&#xD;
  &#xD;
          -  Day one post-operative consult&#xD;
  &#xD;
          -  Day 8 post-operative consult&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          -  History of auto-immune diseases such as Sjögren, Lupus, Graves, Graft-versus-host&#xD;
             disease, rheumatoid arthritis.&#xD;
  &#xD;
          -  History of deafness, anxiety disorders, communicative barrier, impossibility to&#xD;
             comprehend the Visual Analogue Pain Scale or the OSDI questionnaire.&#xD;
  &#xD;
          -  Patient who already had pterygium excision&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in OSDI score POD8</measure>
      <time_frame>Post-op day 8</time_frame>
      <description>The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. Our primary outcome is the difference in OSDI score between both groups after 8 days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary events</measure>
      <time_frame>Post-op day 8</time_frame>
      <description>Number of secondary events in absolute numbers (non-adherence of graft, endophtalmitis, ...)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of OSDI score</measure>
      <time_frame>Post-op day 1 to 8</time_frame>
      <description>The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. A secondary outcome is the mean difference of the OSDI score between both groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain via Visual Analogue Pain Scale at administration of anesthesia</measure>
      <time_frame>Per-operative at administration of anesthesia</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain via Visual Analogue Pain Scale at incision</measure>
      <time_frame>Per-operative at incision</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain via Visual Analogue Pain Scale &lt; 5 minutes after the operation</measure>
      <time_frame>&lt;5 minutes after operation</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain via Visual Analogue Pain Scale 1 day after the operation</measure>
      <time_frame>Post-op day 1</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain via Visual Analogue Pain Scale 8 days after the operation</measure>
      <time_frame>Post-op day 8</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pain via Visual Analogue Pain Scale</measure>
      <time_frame>pre-operative, post-op day 1 and day 8</time_frame>
      <description>We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Pterygium</condition>
    <arm_group>
      <arm_group_label>Topical lidocain gel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will receive topical 2% lidocaine gel (Ophtesic lidocain gel) prior to surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Subconjunctival xylocain injection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G</intervention_name>
      <description>In group A, all patients will receive topical 2% lidocaine gel (ophtesic lidocaine hydrochloride 20 mg/G) prior to surgery.&#xD;
  Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.</description>
      <arm_group_label>Topical lidocain gel</arm_group_label>
      <other_name>Lidocain gel</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Xylocaine with Epinephrine</intervention_name>
      <description>In group B, all patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle. When asked for, patients will receive additional topical 1% lidocaine eye drops.&#xD;
  Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.</description>
      <arm_group_label>Subconjunctival xylocain injection</arm_group_label>
      <other_name>Subconjucntival injection with xylocain injection</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Indication of pterygium excision&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No history of auto-immune diseases such as Sjögren, Lupus, Graves, Graft-versus-host&#xD;
               disease, rheumatoid artritis&#xD;
  &#xD;
            -  No history of deafness, anxiety disorders, communicative barrier, impossibility to&#xD;
               comprehend the Visual Analogue Pain Scale or the OSDI questionnaire.&#xD;
  &#xD;
            -  Patient who already had pterygium excision&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Karolien Termote, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vrije Universiteit Brussel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lennert Hellinckx, Master</last_name>
      <phone>0032 475397266</phone>
      <email>lennert.hellinckx@uzbrussel.be</email>
    </overall_contact>
    <reference>
      <citation>Oksuz H, Tamer C. Efficacy of lidocaine 2% gel in pterygium surgery. Acta Ophthalmol Scand. 2005 Apr;83(2):206-9. doi: 10.1111/j.1600-0420.2005.00404.x.</citation>
      <PMID>15799734</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
      <investigator_full_name>Karolien Termote, MD FEBOpht</investigator_full_name>
      <investigator_title>Ophthalmologist</investigator_title>
    </responsible_party>
    <keyword>Lidocaine gel</keyword>
    <keyword>Pterygium</keyword>
    <keyword>Dryness</keyword>
    <keyword>Irritation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pterygium</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
      <mesh_term>Epinephrine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978687
  org study id: 23149_Pterygium
  nct id: NCT05978687
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an
        uncomfortable and painful step in the procedure. While already being studied in other
        ophthalmic procedures such as glaucoma surgery (7), application of topical lidocaine gel is
        likely to minimize pain. The gel has a longer surface contact time due to its consistency,
        providing not only a longer anesthetic effect, but protecting the corneal surface against
        desiccation, when compared to eye drops.
  
        The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic
        in pterygium excision as subconjunctival injection, while providing more comfort during
        surgery and less corneal dryness afterwards.
  
        Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine
        gel to subconjunctival injection of xylocain 2% solution with 0.125 epinephrine in pterygium
        surgery:
  
          -  Compare the patients pain during and after surgery
  
          -  Compare corneal dryness after surgery.
  
          -  Evaluate possible secondary events
  Pterygia are known as fibrovascular degenerations in the outer layer of the eye. Usually,
        they cross the limbus onto the cornea. they develop over time and can cause symptoms such as
        redness, itching, irritation and decreased vision. In severe cases, pterygiacan provoke
        binocular diplopia due to contraction of the Tenon's capsule. Risk factors are age, UV
        exposure and male gender.
  
        Rezvan F. et al conducted a meta-analysis to study the prevalance of pterygia in the world.
        Their prevalence is estimated at 12% in the worldwide population, being higher in subtropical
        regions. They occur slightly more in men, 13% versus 12%, when compared to women. The highest
        prevalence is seen in patients over 80 years old (up to 19.5%).
  
        The exact mechanism of pathogenesis is not clear. A pterygium consists of degenerated
        collagen tissue. Several previous studies have already proven the role of anti-apoptotic
        proteins such as p53, a tumor suppressor protein. Its expression is elevated when compared to
        normal conjunctival tissue. UV exposure is the most important risk factor. This theory is
        supported by histopathologic actinic changes, similar to actinic keratosis, seen in pterygia.
  
        First line treatment for pterygia are conservative measures, like lubricants and sunglasses
        to protect against additional harmful UV radiation. Yet, these measures are only symptomatic
        and will not eliminate the cause. Surgery is regarded as an ideal solution in patients who
        would like a definitive improvement of esthetic and visual problems. Several surgery
        techniques are already known, but the most common is closure of the excised pterygium with a
        conjunctival auto graft. In this technique, conjunctiva from the superotemporal limbal part
        of the patient's eye is used to cover the excised pterygium area. A systematic review
        compared the risk of recurrence of this technique to the use of an amniotic membrane and
        concluded that the risk of recurrence was 46% percent less in the first group.
  
        These days, subconjunctival injection of xylocain 2% solution with 0.125 epinephrine is the
        most used anesthesia technique. The anesthesia is infero- or superotemporal administered
        5-8mm from the limbus. While giving excellent anesthetic result, the pain and anxiety caused
        by this injection implied the need for new techniques. In chalazion and cataract surgery,
        lidocaine gel is already confirmed to have a sufficient anesthetic effect on patients while
        the amount of pain and anxiety during administration was decreased. In pterygium surgery,
        both and proves that pain was less during both anesthesia administration and
        post-operatively. Now that Ophtesic lidocaine gel is also on-label for pterygium excision, in
        many centers the gel is used as standard of care.
  
        With Oksuz et al. (3) already having investigated the efficacy of lidocaine gel in pterygium
        surgery, there might be more advantages yet to be investigated. For example, the lidocaine
        gel has the advantage of having a viscous consistency. This allows the gel to protect the eye
        from desiccating during surgery. Our primary goal in this study is to compare the ef-fect on
        dryness and irritation in patients after pterygium surgery with both methods of an-aesthesia
        by using the OSDI score questionnaire and the Oxford Dry Scale. In addition to equal
        anaesthetic effect, this could push the standard of care in favour of the lidocaine gel.
  
        In pterygium excision procedures, the subconjunctival injection of xylocain is regarded as an
        uncomfortable and painful step in the procedure. Already proved to be equal, the gel has a
        longer surface contact time due to its consistency, providing not only a longer anesthetic
        effect, but protecting the corneal surface against desiccation, when compared to eye drops.
        Nowadays, it is already considered as the standard of care.
  
        The investigators hypothesize that Ophtesic 2% lidocaine gel is as effective as an anesthetic
        in pterygium excision as subconjunctival injection, while providing more comfort during
        surgery and less corneal dryness afterwards.
  
        Our goal is to compare both the anesthetic and corneal surface effect of topical 2% lidocaine
        gel to subconjunctival injection of xylocain 2% solution with 0.125 epinephrine in pterygium
        surgery:
  
          -  Compare the patients pain during and after surgery
  
          -  Compare corneal dryness after surgery.
  
          -  Evaluate possible secondary events (e.g. enophtalmitis or non-adherence of the graft)
  
        Procedure Anesthesia In group A, all patients will receive topical Povidone- Iodine and 2%
        lidocaine gel prior to surgery. In group B, all patients will receive Povidone- Iodine and a
        subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine
        will be injected with a 27-gauge needle. When asked for, patients will receive additional
        topical 1% lidocaine eye drops.
  
        Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a
        Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is
        removed by blunt dissection. The subconjunctival tissue under the body of the lesion is
        removed. The conjunctival graft is separated from the Tenon's capsule for harvest by
        ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The
        autograft is excised from the superior temporal side. Hereafter, the graft is secured to the
        recipient bed with sutures. The traction suture is removed. All operations are executed by
        the same surgeon.
  
        Following outcomes will be assessed:
  
        • Pain The investigators will monitor pain assessment with the Visual Analogue Pain Scale.
        Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
        The assessment is done intra- and post- operatively by a nurse of the department. During both
        assessments, the surgeon will leave the operating room.
  
        Pain will be monitored at following moments:
  
          -  Initial administration of anesthesia
  
          -  At incision
  
          -  Within 5 minutes after surgery
  
          -  Day one post-operative consult
  
               -  Dryness The dryness is assessed in two manners. The Oxford Dry Eye Scale (11)
                  (Figure two) will be handled as an objective tool to grade dryness. The Ocular
                  Surface Disease Index OSDI (12) (Figure three, four and five) is a subjective
                  manner of assessing dryness. The questionnaire will be available in English, Dutch
                  and French.
  
        At following moments the dryness will be monitored:
  
          -  Day one post-operative consult
  
          -  Day 8 post-operative consult
  
        Exclusion criteria:
  
          -  History of auto-immune diseases such as Sjögren, Lupus, Graves, Graft-versus-host
             disease, rheumatoid arthritis.
  
          -  History of deafness, anxiety disorders, communicative barrier, impossibility to
             comprehend the Visual Analogue Pain Scale or the OSDI questionnaire.
  
          -  Patient who already had pterygium excision
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Difference in OSDI score POD8
  time frame: Post-op day 8
  description: The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. Our primary outcome is the difference in OSDI score between both groups after 8 days.
  measure: Secondary events
  time frame: Post-op day 8
  description: Number of secondary events in absolute numbers (non-adherence of graft, endophtalmitis, ...)
  measure: Change of OSDI score
  time frame: Post-op day 1 to 8
  description: The Ocular Surface Disease Index OSDI (12) is a subjective manner of assessing dryness. The questionnaire will be available in English, Dutch and French. A secondary outcome is the mean difference of the OSDI score between both groups.
  measure: Pain via Visual Analogue Pain Scale at administration of anesthesia
  time frame: Per-operative at administration of anesthesia
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  measure: Pain via Visual Analogue Pain Scale at incision
  time frame: Per-operative at incision
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  measure: Pain via Visual Analogue Pain Scale < 5 minutes after the operation
  time frame: <5 minutes after operation
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  measure: Pain via Visual Analogue Pain Scale 1 day after the operation
  time frame: Post-op day 1
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  measure: Pain via Visual Analogue Pain Scale 8 days after the operation
  time frame: Post-op day 8
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  measure: Change in pain via Visual Analogue Pain Scale
  time frame: pre-operative, post-op day 1 and day 8
  description: We will monitor pain assessment with the Visual Analogue Pain Scale. Patients will be asked to give a score from 0 (no pain at all) to 10 (worst pain imaginable).
  arm group label: Topical lidocain gel
  arm group type: Experimental
  description: All patients will receive topical 2% lidocaine gel (Ophtesic lidocain gel) prior to surgery
  arm group label: Subconjunctival xylocain injection
  arm group type: Active Comparator
  description: All patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle
  intervention type: Drug
  intervention name: OPHTESIC LIDOCAINE HYDROCHLORIDE 20MG/G
  description: In group A, all patients will receive topical 2% lidocaine gel (ophtesic lidocaine hydrochloride 20 mg/G) prior to surgery.
  Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.
  arm group label: Topical lidocain gel
  other name: Lidocain gel
  intervention type: Drug
  intervention name: Xylocaine with Epinephrine
  description: In group B, all patients will receive a subconjunctival injection with xylocaine 2% hydrochloride solution with 0.125 epinephrine will be injected with a 27-gauge needle. When asked for, patients will receive additional topical 1% lidocaine eye drops.
  Operative technique A traction suture is applied at the superior limbus (Vicryl 6.0) with a Kocher. The head of the pterygium is separated from its body with scissors. Afterwards it is removed by blunt dissection. The subconjunctival tissue under the body of the lesion is removed. The conjunctival graft is separated from the Tenon's capsule for harvest by ballooning with SBSS in group A and by injection with 0.5 mL of 2% xylocaine in group B. The autograft is excised from the superior temporal side. Hereafter, the graft is secured to the recipient bed with sutures. The traction suture is removed. All operations are executed by the same surgeon.
  arm group label: Subconjunctival xylocain injection
  other name: Subconjucntival injection with xylocain injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Karolien Termote, Master
  role: Principal Investigator
  affiliation: Vrije Universiteit Brussel
  last name: Lennert Hellinckx, Master
  phone: 0032 475397266
  email: lennert.hellinckx@uzbrussel.be
  citation: Oksuz H, Tamer C. Efficacy of lidocaine 2% gel in pterygium surgery. Acta Ophthalmol Scand. 2005 Apr;83(2):206-9. doi: 10.1111/j.1600-0420.2005.00404.x.
  PMID: 15799734
  responsible party type: Principal Investigator
  investigator affiliation: Vrije Universiteit Brussel
  investigator full name: Karolien Termote, MD FEBOpht
  investigator title: Ophthalmologist
  mesh term: Pterygium
  mesh term: Lidocaine
  mesh term: Epinephrine
  sharing ipd: No