Smartphone App for Taking Images of Conjunctivae

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Brief Title

Smartphone App for Taking Images of Conjunctivae

Official Title

Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Development of a Smartphone Application to Capture Quality Images of Everted Eye Lids and Assessment of Its Acceptability and Feasibility

Brief Summary

      Trachomatous inflammation-follicular (TF) is diagnosed by looking for clinical signs of
      infection of everted eyelids (conjunctivae) of children.

      The overall objective of this project is to develop a smartphone application and assess its
      acceptability and feasibility.

      Fieldwork will take place during routine Tropical Data trainings and population-based
      prevalence surveys supported by Tropical Data.

      Healthy adult volunteers in London will have photos of their conjunctivae taken to develop
      the app initially, with iterative improvements to the app based on image quality achieved.
      For fieldwork, images of the conjunctivae of children will be have photos of their
      conjunctivae taken with a digital single lens reflex (DSLR) camera and the newly developed
      smartphone app. Grading of the photos will be compared with field grading, to compare grading
      agreement, to assess utility for supervision, quality assurance and training purposes.
    

Detailed Description

      The investigators want to see whether it would be possible to take photos using Android
      smartphones, routinely used in trachoma surveys for collecting data, for quality assurance,
      supervision and training purposes. The investigators will develop an app in the United
      Kingdom (UK) by taking photos of the conjunctivae of healthy adult volunteers to iteratively
      improve the quality of images based on the image metadata and review by trachoma experts. The
      app will then be field tested, and trachoma grading based on the app photos, DSLR photos, and
      clinical grading, compared. Any management (treatment) will be based on routine clinical
      diagnosis only - the images are for research purposes only. The investigators will also ask
      participants for their views on acceptability of having photos of conjunctivae taken with the
      phone, and conduct a cost-consequences analysis of potential implementation of the app in
      routine trachoma surveys.

      Objectives and approach:

      2.1 To develop a mobile phone application to capture images of everted eyelids (conjunctivae)
      of children being examined as part of the Tropical Data field inter-grader agreement (IGA)
      test, or sampled as part of trachoma prevalence surveys.

      2.2 To evaluate the quality of the mobile phone application images compared with field
      grading and DSLR images.

      2.3 To assess the acceptability and feasibility of a mobile phone application for
      photographing everted eyelids (conjunctivae) from children being examined as part of the
      Tropical Data IGA test, or sampled as part of trachoma prevalence surveys.

      2.4 To conduct a cost-consequences analysis of setting up an infrastructure for capturing and
      transmitting images in order to make the system economically viable.
    


Study Type

Interventional


Primary Outcome

TOols For Trachoma Elimination Endgame (TOFTEE) app image quality

Secondary Outcome

 Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality

Condition

Trachoma

Intervention

TOFTEE

Study Arms / Comparison Groups

 Children examined
Description:  All children examined for clinical signs of trachoma will be invited to participate to have photos of conjunctivae taken with the TOFTEE smartphone app and a DSLR camera.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

125

Start Date

July 8, 2019

Completion Date

September 30, 2021

Primary Completion Date

July 12, 2019

Eligibility Criteria

        Inclusion Criteria:

        Objectives 2.1 and 2.2:

          -  For the London-based app development, any eligible healthy adult who provides written
             informed consent will be eligible.

          -  For the field-based app development, any child aged 1-9 years being examined as part
             of the Tropical Data IGA test, or sampled as part of trachoma prevalence surveys, and
             for whom written informed consent has been provided by a guardian, will be eligible.

        Objective 2.3:

          -  All Tropical Data trainers and trainees attending the Tropical Data (initial and
             refresher) training events and who provide written informed consent, will be eligible.

          -  Community leaders and children's guardians who provide written informed consent will
             be eligible.

        Exclusion Criteria:

          -  For each of the objectives, if the inclusion criteria are not fulfilled, the
             participant will not be eligible to participate.
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Emma Harding-Esch, , 

Location Countries

Tanzania

Location Countries

Tanzania

Administrative Informations


NCT ID

NCT03997487

Organization ID

2019-KEP-284 - 2


Responsible Party

Sponsor

Study Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

 National Institute for Medical Research, Tanzania

Study Sponsor

Emma Harding-Esch, Principal Investigator, LSHTM


Verification Date

September 2020