Using Rose Bengal and Green Light to Treat Bacterial Eye Infections
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
This study is testing if a new treatment using Rose Bengal and green light can help people with bacterial eye infections see better compared to standard treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (São Paulo and 1 other locations) |
| Trial ID | NCT06271772 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Rose Bengal Electromagnetic Activation combined with green light therapy in treating bacterial keratitis. It is a randomized, double-masked feasibility study comparing standard antimicrobial treatments to those enhanced with Rose Bengal photodynamic therapy. Patients with smear-positive or culture-positive bacterial corneal ulcers and significant vision loss will be enrolled and assigned to one of two treatment groups. The primary outcome is the difference in visual acuity after six months of treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with smear-positive or culture-positive bacterial corneal ulcers and moderate to severe vision loss.
Not a fit: Patients with concomitant infections, severe corneal damage, or non-infectious keratitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vision outcomes for patients suffering from bacterial keratitis.
How similar studies have performed: Previous studies have shown promise with photodynamic therapy in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria) * Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse * Corneal thickness ≥350 µm, as measured on AS-OCT * Age over 18 years * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion Criteria: * Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * Impending or frank perforation at recruitment * Involvement of sclera at presentation * Presence of desmetocele at recruitment * Non-infectious or autoimmune keratitis * History of corneal transplantation * History of intraocular surgery within the last three months\* * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired
Where this trial is running
São Paulo and 1 other locations
- Federal University of São Paulo — São Paulo, Brazil (Recruiting)
- Aravind Eye Care System — Madurai, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Jennifer Rose-Nussbaumer, MD — Stanford University
- Study coordinator: Jennifer Rose-Nussbaumer, MD
- Email: rosej@stanford.edu
- Phone: 650-402-8820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.