<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/NCT04408807</url>
  </required_header>
  <id_info>
    <org_study_id>414/08-05-2019</org_study_id>
    <nct_id>NCT04408807</nct_id>
  </id_info>
  <brief_title>Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided</brief_title>
  <acronym>stressROP</acronym>
  <official_title>Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</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>
      The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of&#xD;
      prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral&#xD;
      indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp)&#xD;
      and scleral indentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized cross-over study was conducted for the comparison of the two&#xD;
      techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a&#xD;
      speculum and indentor. A random number table was used to allocate participants into either a)&#xD;
      receiving Sp funduscopy on their first and SpF on their second screening examination a week&#xD;
      later, or b) receiving SpF first and Sp a week later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 4, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Premature Infant Pain Profile-Revised score (PIPP)</measure>
    <time_frame>a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crying score of the Bernese pain scale</measure>
    <time_frame>During the examination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance</measure>
    <time_frame>During the examination and during the 24 hours after the examination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequacy of judging the presence of treatment-requiring ROP</measure>
    <time_frame>At the end of ROPEE screening</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of fundoscopy</measure>
    <time_frame>During the examination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Retinopathy of Prematurity</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ROPEE screening with speculum-free fundoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ROPEE screening with speculum fundoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Speculum-free (SpF) fundoscopy</intervention_name>
    <description>Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Speculum (Sp) fundoscopy</intervention_name>
    <description>Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Preterm neonates undergoing screening for ROP, i.e.&#xD;
&#xD;
          -  with GA &lt; 32weeks and/or BW &lt; 1501grams&#xD;
&#xD;
          -  infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need&#xD;
             for oxygen supplementation etc., as judged by the attending neonatologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe clinical condition with unstable vital signs to the extent that stress is not&#xD;
             desired and the examination need to be postponed.&#xD;
&#xD;
          2. Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.&#xD;
&#xD;
          3. Neonates under sedative/analgesic treatment.&#xD;
&#xD;
          4. Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment,&#xD;
             other conditions that could alter pain response.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Weeks</minimum_age>
    <maximum_age>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>&quot;Papageorgiou&quot; Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.</citation>
    <PMID>19815939</PMID>
  </reference>
  <reference>
    <citation>Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.</citation>
    <PMID>16828505</PMID>
  </reference>
  <reference>
    <citation>Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.</citation>
    <PMID>15814220</PMID>
  </reference>
  <reference>
    <citation>Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08.</citation>
    <PMID>8120743</PMID>
  </reference>
  <results_reference>
    <citation>Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.</citation>
    <PMID>34939742</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Asimina Mataftsi</investigator_full_name>
    <investigator_title>Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Retinopathy of Prematurity</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04408807
org study id: 414/08-05-2019
nct id: NCT04408807
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of
      prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral
      indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp)
      and scleral indentation.
A prospective randomized cross-over study was conducted for the comparison of the two
      techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a
      speculum and indentor. A random number table was used to allocate participants into either a)
      receiving Sp funduscopy on their first and SpF on their second screening examination a week
      later, or b) receiving SpF first and Sp a week later.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Premature Infant Pain Profile-Revised score (PIPP)
time frame: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]
measure: Crying score of the Bernese pain scale
time frame: During the examination
measure: Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
time frame: During the examination and during the 24 hours after the examination
measure: Adequacy of judging the presence of treatment-requiring ROP
time frame: At the end of ROPEE screening
measure: Duration of fundoscopy
time frame: During the examination
arm group label: Study Group
arm group type: Experimental
description: ROPEE screening with speculum-free fundoscopy
arm group label: Control Group
arm group type: Active Comparator
description: ROPEE screening with speculum fundoscopy
intervention type: Other
intervention name: Speculum-free (SpF) fundoscopy
description: Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
arm group label: Study Group
intervention type: Other
intervention name: Speculum (Sp) fundoscopy
description: Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
arm group label: Control Group
criteria: 
gender: All
minimum age: 30 Weeks
maximum age: 37 Weeks
healthy volunteers: No
facility: 
country: Greece
citation: Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.
PMID: 19815939
citation: Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.
PMID: 16828505
citation: Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.
PMID: 15814220
citation: Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08.
PMID: 8120743
citation: Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.
PMID: 34939742
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Asimina Mataftsi
investigator title: Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
sharing ipd: No