<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/NCT03278587</url>
  </required_header>
  <id_info>
    <org_study_id>17-22776</org_study_id>
    <nct_id>NCT03278587</nct_id>
  </id_info>
  <brief_title>Village-Integrated Eye Worker Trial II - Pilot</brief_title>
  <acronym>VIEW II Pilot</acronym>
  <official_title>Village-Integrated Eye Worker Trial II - Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seva Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bharatpur Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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 vast majority of blindness is avoidable. The World Health Organization (WHO) estimates&#xD;
      that 80% of cases of visual impairment could be prevented or reversed with early diagnosis&#xD;
      and treatment. The leading causes of visual impairment are cataract and refractive error,&#xD;
      followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR).&#xD;
      Loss of vision from these conditions is not inevitable; however, identifying at-risk cases&#xD;
      and linking cases with appropriate care remain significant challenges.&#xD;
&#xD;
      Worldwide, eye health care systems must determine optimal strategies for reaching people&#xD;
      outside of their immediate orbit in order to reduce visual impairment. Visual impairment can&#xD;
      be reduced by case detection of prevalent disease like cataract and refractive error, or by&#xD;
      screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems&#xD;
      around the world have developed numerous approaches to both case detection and screening but&#xD;
      there is very little research to support the choice of allocating resources to case detection&#xD;
      or screening and little data exists on the cost effectiveness of the various approaches to&#xD;
      each.&#xD;
&#xD;
      VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different&#xD;
      approaches to community-based case detection and screening for ocular disease. Communities in&#xD;
      Nepal will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2)&#xD;
      a cataract camp-based program, 3) a community health worker-based program, and 4) no program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: to determine whether screening leads to increased visual acuity compared to&#xD;
      the cataract camp approach.&#xD;
&#xD;
      Specific Aim 2: to determine whether a community health volunteer program increases the rate&#xD;
      of cataract surgery compared to a no program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>Primary outcome for specific aim 1, comparison between screening and case detection arms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cataract surgical rate</measure>
    <time_frame>1 year</time_frame>
    <description>Primary outcome for specific aim 2, comparison between community health worker program and no program arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>1 year</time_frame>
    <description>Cost-effectiveness of all 4 arms will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>Visual acuity of population 50 years and older in all arms will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases of ocular disease detected</measure>
    <time_frame>1 year</time_frame>
    <description>Number of cases of ocular disease in the screening and case detection arms will be compared</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16075</enrollment>
  <condition>Cataract</condition>
  <condition>Glaucoma</condition>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Refractive Errors</condition>
  <arm_group>
    <arm_group_label>Community-based screening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cataract camp program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Community health worker program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community-based screening program</intervention_name>
    <description>In communities randomized to receive the screening program, all adults aged 50 and older will be eligible to receive screening for ocular disease. Screening assessments include visual acuity, refraction, intra-ocular pressure, fundus photography, and anterior segment photography. Participants meeting criteria for referral based on screening assessments will be referred to the nearest eye care center or eye hospital for further evaluation.</description>
    <arm_group_label>Community-based screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cataract camp program</intervention_name>
    <description>In communities randomized to receive the cataract camp program, all adults aged 50 and older will be eligible to participate in a routine cataract camp run by Bharatpur Eye Hospital. Trained ophthalmic personnel and assistants will perform case detection for cataract via visual acuity, pen light exam, and indirect ophthalmoscope exam per Bharatpur Eye Hospital's standard cataract camp program. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.</description>
    <arm_group_label>Cataract camp program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community health worker program</intervention_name>
    <description>In communities randomized to receive the community health worker program, all adults aged 50 and older will be eligible to participate. Existing community health workers will be trained to perform case detection for cataract via visual acuity assessment. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.</description>
    <arm_group_label>Community health worker program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria(community-level):&#xD;
&#xD;
          -  Wards in the Chitwan and Nawalparasi districts that participated in the VIEW trial and&#xD;
             have not received a cataract camp in the past 6 months.&#xD;
&#xD;
        Inclusion Criteria (individual-level):&#xD;
&#xD;
          -  Individuals aged 50 and older will be eligible to participate in the screening&#xD;
             program, cataract camp programs, and the FCHV program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy D Keenan, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bharatpur Eye Hospital</name>
      <address>
        <city>Bharatpur</city>
        <state>Chitwan</state>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_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/NCT03278587
org study id: 17-22776
nct id: NCT03278587
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates
      that 80% of cases of visual impairment could be prevented or reversed with early diagnosis
      and treatment. The leading causes of visual impairment are cataract and refractive error,
      followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR).
      Loss of vision from these conditions is not inevitable; however, identifying at-risk cases
      and linking cases with appropriate care remain significant challenges.

      Worldwide, eye health care systems must determine optimal strategies for reaching people
      outside of their immediate orbit in order to reduce visual impairment. Visual impairment can
      be reduced by case detection of prevalent disease like cataract and refractive error, or by
      screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems
      around the world have developed numerous approaches to both case detection and screening but
      there is very little research to support the choice of allocating resources to case detection
      or screening and little data exists on the cost effectiveness of the various approaches to
      each.

      VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different
      approaches to community-based case detection and screening for ocular disease. Communities in
      Nepal will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2)
      a cataract camp-based program, 3) a community health worker-based program, and 4) no program.
Specific Aim 1: to determine whether screening leads to increased visual acuity compared to
      the cataract camp approach.

      Specific Aim 2: to determine whether a community health volunteer program increases the rate
      of cataract surgery compared to a no program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Visual acuity
time frame: 1 year
description: Primary outcome for specific aim 1, comparison between screening and case detection arms
measure: Cataract surgical rate
time frame: 1 year
description: Primary outcome for specific aim 2, comparison between community health worker program and no program arms
measure: Cost-effectiveness
time frame: 1 year
description: Cost-effectiveness of all 4 arms will be assessed
measure: Visual acuity
time frame: 1 year
description: Visual acuity of population 50 years and older in all arms will be compared
measure: Number of cases of ocular disease detected
time frame: 1 year
description: Number of cases of ocular disease in the screening and case detection arms will be compared
arm group label: Community-based screening
arm group type: Active Comparator
arm group label: Cataract camp program
arm group type: Active Comparator
arm group label: Community health worker program
arm group type: Active Comparator
arm group label: No intervention
arm group type: No Intervention
intervention type: Other
intervention name: Community-based screening program
description: In communities randomized to receive the screening program, all adults aged 50 and older will be eligible to receive screening for ocular disease. Screening assessments include visual acuity, refraction, intra-ocular pressure, fundus photography, and anterior segment photography. Participants meeting criteria for referral based on screening assessments will be referred to the nearest eye care center or eye hospital for further evaluation.
arm group label: Community-based screening
intervention type: Other
intervention name: Cataract camp program
description: In communities randomized to receive the cataract camp program, all adults aged 50 and older will be eligible to participate in a routine cataract camp run by Bharatpur Eye Hospital. Trained ophthalmic personnel and assistants will perform case detection for cataract via visual acuity, pen light exam, and indirect ophthalmoscope exam per Bharatpur Eye Hospital's standard cataract camp program. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
arm group label: Cataract camp program
intervention type: Other
intervention name: Community health worker program
description: In communities randomized to receive the community health worker program, all adults aged 50 and older will be eligible to participate. Existing community health workers will be trained to perform case detection for cataract via visual acuity assessment. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
arm group label: Community health worker program
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeremy D Keenan, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: Nepal
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Cataract
mesh term: Diabetic Retinopathy
mesh term: Refractive Errors