Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01969786
Other study ID # U10EY02280
Secondary ID 5U10EY022880
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date January 2025

Study information

Verified date March 2024
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention.


Description:

Corneal ulceration is a leading cause of visual impairment globally, with a disproportionate burden in developing countries. Corneal opacity after ulceration is responsible for a significant proportion of blinding eye disease in Africa and Asia. While antimicrobial treatment is generally effective in eradicating infection, "successful" treatment is often associated with a poor visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. It has been difficult to discern differences between different antimicrobials in a randomized controlled trial (RCT). In fact, only a single RCT with more than 50 subjects has found any significant difference between ulcer treatments. Thus, prevention of corneal ulceration may be our best opportunity to reduce morbidity associated with corneal ulceration. Several non-randomized prevention studies in Nepal, Myanmar, and Bhutan have suggested that antibiotic ointment applied promptly after a corneal abrasion could dramatically lower the incidence of ulcers, relative to neighboring or historic controls. In Madurai, South India, a clinical trial demonstrated that abrasions randomized to topical antibacterial and antifungal prophylaxis were not significantly less likely to develop fungal ulcers than those randomized to antibacterial ointment alone, even though the region had a high incidence of fungal infection. This same trial also found that the incidence of ulcers in villages outside the prophylaxis program was far higher; these control villages were neighboring but not randomized, and it is possible that they were in some way different from the villages included in the program. VIEW was designed to determine whether we can prevent corneal ulcers on a large scale. VIEW is a community-randomized trial comparing villages randomized to receive an intervention consisting of a trained community health volunteer providing antimicrobial ointment after 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 36 months. The examiners will photograph corneas of all residents who are suspected of having a corneal ulcer, with photographs later read by masked examiners. Each resident in the village will be examined for evidence of a corneal opacity and asked about their ocular history. In villages randomized to intervention, the trained community health volunteers will actively promote their services through regular meetings with local women's groups by encouraging 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 223671
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Presence of a corneal abrasion - Willingness to be treated with topical antibiotic and antifungal ointments 3 times a day for 3 days - Appropriate consent Exclusion Criteria: - Evidence of a corneal ulcer - Evidence of other acute eye disease requiring urgent care - Known allergy to study medications - Not willing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Corneal ulcer prevention program
The corneal ulcer prevention intervention consists of training female community health volunteers to diagnose corneal abrasions and to treat the abrasions with 1% itraconazole and 1% chloramphenicol ointments 3 times a day for 3 days.

Locations

Country Name City State
Nepal Bharatpur Eye Hospital - Seva Foundation Bharatpur

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco Bharatpur Eye Hospital, National Eye Institute (NEI), Seva Foundation

Country where clinical trial is conducted

Nepal, 

References & Publications (1)

O'Brien KS, Byanju R, Kandel RP, Poudyal B, Gautam M, Gonzales JA, Porco TC, Whitcher JP, Srinivasan M, Upadhyay M, Lietman TM, Keenan JD; Village-Integrated Eye Worker Trial Group. Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings. BMJ Open. 2018 Aug 10;8(8):e021556. doi: 10.1136/bmjopen-2018-021556. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of corneal ulceration in the non-intervention arm corrected by passive surveillance 3 years
Other Long-term follow-up of incidence of corneal ulceration in the two study arms as measured by corneal photography 5 years
Primary Incidence of corneal ulceration in the two study arms as measured by corneal photography 3 years
Secondary Trial-based cost effectiveness analysis to determine the incremental cost per corneal ulcer prevented 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05705024 - Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells Phase 2
Completed NCT02731638 - Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers Phase 3
Completed NCT00324168 - Steroids for Corneal Ulcers Trial Phase 4
Completed NCT04484402 - Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells Phase 1/Phase 2
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Recruiting NCT02570321 - Cross-linking for Corneal Ulcers Treatment Trial Phase 4
Completed NCT00386958 - A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers Phase 2
Completed NCT04054817 - ACRO Biocornea Clinical Trial in Taiwan N/A
Completed NCT00997035 - The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo Phase 3
Completed NCT02277054 - Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty N/A
Recruiting NCT05313828 - Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Recruiting NCT05255016 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers Phase 2/Phase 3
Recruiting NCT05255107 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers Phase 2/Phase 3
Completed NCT05891106 - AONDA Therapeutic Indication Study I
Terminated NCT00789646 - Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients N/A
Not yet recruiting NCT05940376 - Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy
Completed NCT05200000 - Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis Phase 1
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Completed NCT01794312 - Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer Phase 3
Completed NCT04837534 - Improving the Follow up Rate for Pediatric Patients N/A