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Clinical Study for treatment of Eye infection

RB-PDT (Rose Bengal- Photo Dynamic Therapy) for Fusarium Keratitis - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109013
Enrollment
434
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H160- Corneal ulcer

Interventions

Intervention1: Participants will undergo cornea cross linking with Rose bengal 0.1% dye eye drops using Green light: 15 minutes in the study eye Control Intervention1: Balanced salt solution will be i

Sponsors

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Presence of culture positive fusarium fungal keratitis 2) Age over 18 years 3) Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse 4) Corneal thickness 350 m as measured on AS OCT 5) Basic understanding of the study as determined by the physician 6) Commitment to return for follow up visits

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity to Rose Bengal 2) Evidence of concomitant infection on exam, gram stain, or confocal microscopy 3) History of intraocular surgery within the last three months 4) Impending or frank perforation at recruitment 5) Involvement of sclera at presentation 6) Presence of desmetocele at recruitment 7) Non-infectious or autoimmune keratitis 8) History of corneal transplantation 9) Pinhole visual acuity worse than 20/200 in the unaffected eye 10) Participants who are decisionally and/or cognitively impaired

Design outcomes

Primary

MeasureTime frame
Improved visual acuity among those randomized to Rose Bengal Photo Dynamic Therapy after controlling for baseline visual acuity Timepoint: 3 MONTHS

Secondary

MeasureTime frame
There should be smaller infiltrate scar size and decreased rate of perforation and need for Therapeutic Penetrating Keratoplasty at 6 months among Rose Bengal Photo Dynamic Therapy treated participants Timepoint: 6 months

Countries

Brazil, India, United States of America

Contacts

Public ContactDr N Venkatesh Prajna

Aravind Eye Hospital and PG Institute of Ophthalmology

prajna@aravind.org914524356100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026