TrachomaNCT03997487
Smartphone App for Taking Images of Conjunctivae
A study testing TOFTEE in people with Trachoma, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- TOFTEE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTanzania
- Study dates
- 8 Jul 2019to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- For each of the objectives, if the inclusion criteria are not fulfilled, the participant will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Trachoma
- Being tested
- TOFTEE
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOFTEEOther
Smartphone app for taking quality images of conjunctivae
| Study group | Role | What they receive |
|---|---|---|
| Children examined | Experimental | 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. Receives: Other: TOFTEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOols For Trachoma Elimination Endgame (TOFTEE) app image quality
Photo quality will be assessed by trachoma grading experts. The technical parameters such as lighting, resolution, focus, etc. will be assessed using objective software or extracted from the photograph metadata.
Measured: 30 minutes
Kappa score of TOFTEE image compared with field grading
Concordance in diagnosis of trachoma between field grading and app image
Measured: 5 minutes
Kappa score of TOFTEE image compared with DSLR grading
Concordance in diagnosis of trachoma between app image and DSLR image
Measured: 5 minutes
Kappa score of DSLR image compared with field grading
Concordance in diagnosis of trachoma between field grading and DSLR image
Measured: 5 minutes
Secondary outcomes (4)
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics acceptable photo quality
Measured: 15 minutes
Acceptability and feasibility of TOFTEE app in communities
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app in communities
Measured: 45 minutes
Acceptability and feasibility of TOFTEE app in Tropical Data system
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app as part of the Tropical Data system
Measured: 45 minutes
Cost of TOFTEE app implementation
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of TOFTEE app implementation into the Tropical Data system
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start8 Jul 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
- Responsible party
- Sponsor
- Investigators
- Emma Harding-Esch, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997487
- Sponsor's protocol ID
- 2019-KEP-284 - 2
- Status last verified
- May 2022
- First submitted
- 19 Jun 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03997487
- Acronym / sponsor ID
- 2019-KEP-284 - 2
- Conditions
- Trachoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 125 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children examined | Experimental | Other: TOFTEEAll 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- For each of the objectives, if the inclusion criteria are not fulfilled, the participant will not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOFTEESmartphone app for taking quality images of conjunctivae | Other | Children examined |
Primary outcome
TOols For Trachoma Elimination Endgame (TOFTEE) app image quality
Time frame: 30 minutes
Photo quality will be assessed by trachoma grading experts. The technical parameters such as lighting, resolution, focus, etc. will be assessed using objective software or extracted from the photograph metadata.
Kappa score of TOFTEE image compared with field grading
Time frame: 5 minutes
Concordance in diagnosis of trachoma between field grading and app image
Kappa score of TOFTEE image compared with DSLR grading
Time frame: 5 minutes
Concordance in diagnosis of trachoma between app image and DSLR image
Kappa score of DSLR image compared with field grading
Time frame: 5 minutes
Concordance in diagnosis of trachoma between field grading and DSLR image
4 secondary outcomes
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality
Time frame: 15 minutes
Acceptability and feasibility of TOFTEE app in communities
Time frame: 45 minutes
Acceptability and feasibility of TOFTEE app in Tropical Data system
Time frame: 45 minutes
Cost of TOFTEE app implementation
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Related trials for Trachoma
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Harding-Esch principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOFTEE in people with Trachoma, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOols For Trachoma Elimination Endgame (TOFTEE) app image quality (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.