Smartphone App for Taking Images of Conjunctivae

NCT ID: NCT03997487

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2019-07-12

Brief Summary

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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

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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.

Conditions

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Trachoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Children examined

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.

Group Type EXPERIMENTAL

TOFTEE

Intervention Type OTHER

Smartphone app for taking quality images of conjunctivae

Interventions

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TOFTEE

Smartphone app for taking quality images of conjunctivae

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Federal Minstry of Health of Ethiopia

OTHER_GOV

Sponsor Role collaborator

Jos University Teaching Hospital

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

Sightsavers

UNKNOWN

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Pan American Health Organization

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma Harding-Esch

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Arusha region

Arusha, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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2019-KEP-284 - 2

Identifier Type: -

Identifier Source: org_study_id

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