Corneal UlcerCUPNCT02284698
Corneal Ulcer Prevention Through Health Education
An observational study of Corneal Ulcer, run by Aravind Eye Care System.
Trial summary
A community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer who brings patients to the nearest Vision Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to control villages receiving no additional… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- Health Education
- How many people
- 98,207 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2017
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 42 villages eligible for the study will comprise a total population of 98,207
Who may be able to join
- Presence of a corneal abrasion
- Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
- Appropriate consent
Who cannot join
- Evidence of a corneal ulcer
- Evidence of other acute eye disease requiring urgent care
- Known allergy to study medications
- Not willing to participate
Trial locations and contacts
No sites are listed yet.
About this study
A community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer who brings patients to the nearest Vision Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 24 months. Each resident in the village will be asked about their ocular history and, if suspected of having a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will occur, coinciding with the end of the harvest season. In villages randomized to intervention, an active promotion campaign will be undertaken to urge residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.
Read the detailed description
Research Question: Can the investigators prevent corneal ulcers on a mass scale?
Aim 1: To determine whether diagnosis and prophylaxis of corneal abrasions by village health workers will reduce the incidence of corneal ulceration in rural South India. The investigators hypothesize that communities in which village eye health workers are available to diagnose and prophylax corneal abrasions will have a significantly lower incidence of corneal ulceration compared to communities without this service.
Aim 2: To determine the cost-effectiveness of a village eye worker program to prevent corneal ulcers. The investigators hypothesize that preventing corneal ulcers through a village eye worker program will be more cost-effective than the current standard of treating corneal ulcers after patients present at health care facilities.
Aim 3: To determine the incidence of corneal ulceration in this South Indian population. The investigators anticipate that the incidence of ulcers is lower than estimated in our 1995 incidence survey, but still far higher than that observed in the developed world.
- Conditions
- Corneal Ulcer
- Being tested
- Health Education
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationOther
Heath education will be given through awareness creation \& pamphlet distribution
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Study Group will have the field workers and active health education with referral mechanism Receives: Other: Health Education | |
| Control Group | Control group will not have field workers and active health education. They will follow routine health care Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Corneal Ulcer
The primary outcome for the trial will be the incidence of corneal ulceration in the two study arms as measured by field examination.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal UlcerStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 98,207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aravind Eye Care System
- Sponsor type
- University, hospital or other
- Collaborators
- Proctor Foundation
- Responsible party
- Principal investigator, Dr. M.Srinivasan, Aravind Eye Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284698
- Sponsor's protocol ID
- Aravind-RES2013064CLI
- Acronym
- CUP
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Srinivasan M, Ravilla T, Vijayakumar V, Yesunesan D, Mani I, Whitcher JP, Oldenburg CE, O'Brien KS, Lietman TM, Keenan JD. Community Health Workers for Prevention of Corneal Ulcers in South India: A Cluster-Randomized Trial. Am J Ophthalmol. 2022 May;237:259-266. doi: 10.1016/j.ajo.2021.12.010. Epub 2021 Dec 21.
PubMed 34942106
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Ulcer Prevention Through Health Education
- ClinicalTrials.gov ID
- NCT02284698
- Acronym / sponsor ID
- CUP / Aravind-RES2013064CLI
- Conditions
- Corneal Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98,207 participants (estimated)
- Lead sponsor
- Aravind Eye Care SystemUniversity, hospital or other
- Collaborators
- Proctor Foundation
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- 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.
A community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer who brings patients to the nearest Vision Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to control villages receiving no additional intervention. The primary outcome of corneal ulcer will be measured by baseline and annual population-based census performed in both intervention and control villages by masked examiners from baseline to 24 months. Each resident in the village will be asked about their ocular history and, if suspected of having a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will occur, coinciding with the end of the harvest season. In villages randomized to intervention, an active promotion campaign will be undertaken to urge residents to notify the village eye health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers will be treated if they present to a clinic or are found during the annual monitoring visits, but active promotion of corneal abrasion care will not be offered.
Detailed description
Research Question: Can the investigators prevent corneal ulcers on a mass scale?
Aim 1: To determine whether diagnosis and prophylaxis of corneal abrasions by village health workers will reduce the incidence of corneal ulceration in rural South India. The investigators hypothesize that communities in which village eye health workers are available to diagnose and prophylax corneal abrasions will have a significantly lower incidence of corneal ulceration compared to communities without this service.
Aim 2: To determine the cost-effectiveness of a village eye worker program to prevent corneal ulcers. The investigators hypothesize that preventing corneal ulcers through a village eye worker program will be more cost-effective than the current standard of treating corneal ulcers after patients present at health care facilities.
Aim 3: To determine the incidence of corneal ulceration in this South Indian population. The investigators anticipate that the incidence of ulcers is lower than estimated in our 1995 incidence survey, but still far higher than that observed in the developed world.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Health EducationStudy Group will have the field workers and active health education with referral mechanism |
| Control Group | – | Other: Health EducationControl group will not have field workers and active health education. They will follow routine health care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 42 villages eligible for the study will comprise a total population of 98,207
Key inclusion criteria (3 listed)
- Presence of a corneal abrasion
- Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days
- Appropriate consent
Key exclusion criteria (4 listed)
- Evidence of a corneal ulcer
- Evidence of other acute eye disease requiring urgent care
- Known allergy to study medications
- Not willing 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 |
|---|---|---|
| Health EducationHeath education will be given through awareness creation \& pamphlet distribution | Other | Control Group, Study Group |
Primary outcome
Incidence of Corneal Ulcer
Time frame: 2 years
The primary outcome for the trial will be the incidence of corneal ulceration in the two study arms as measured by field examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 34942106Srinivasan M, Ravilla T, Vijayakumar V, Yesunesan D, Mani I, Whitcher JP, Oldenburg CE, O'Brien KS, Lietman TM, Keenan JD. Community Health Workers for Prevention of Corneal Ulcers in South India: A Cluster-Randomized Trial. Am J Ophthalmol. 2022 May;237:259-266. doi: 10.1016/j.ajo.2021.12.010. Epub 2021 Dec 21.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ulcer, run by Aravind Eye Care System.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Srinivasan M, MS, DO (+914524356100 ext. 311, m.srinivasan@aravind.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Corneal Ulcer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284698, which also lists 1 linked publication.
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 6 Nov 2014.