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To see the efficacy of PDAT with Rose Bengal on cases with fungal keratitis

Randomized comparative trial for testing the efficacy of PDAT with Rose Bengal on cases with fungal keratitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030780
Enrollment
120
Registered
2021-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Health Condition 2: H160- Corneal ulcer

Interventions

Intervention1: Photodynamic antimicrobial therapy along with empty fungus: 1. Natamycin 5% along with Tab Ketoconazole 200 mg twice a day. 2. All patients receive 2 PDAT treatments one week apart. 3.

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All cases with microbial keratitis with the infiltrate size between 2-6 mm with anterior to mid stromal involvement and confirmed on smears and/or culture as Fungus by Microbiologist. 2. Ready to give consent 3. Consent for regular follow-up 4. Patients with age >=18 years, 5. Duration of complaints not more than the past 14 days before presentation. 6. The widest diameter of the ulcer needed to be between 2 and 6 mm as long as there was no scleral involvement. 7. At the time of recruitment, either none or inadequate prior treatment 8. with antifungal eye drop (less than six times per day)

Exclusion criteria

Exclusion criteria: 1. Mixed infection on smears or cultures 2. Not willing to come for regular follow-up or admission or giving consent 3. Posterior stromal involvement 4. Severe fungal keratitis, with Limbal involvement 5. One eyed patient (other eye vision if less than 6/60 due to unmodifiable causes) 6. Allergic to Rose Bengal 7. Any associated collagen vascular disease 8. With impending or actual corneal perforation, 9. Presence of scleral involvement or involvement of posterior one-third 10. stroma 11. Legally blind unaffected eye, 12. Presence of corneal anaesthesia, exposure or dry eye 13. Patients who received/required topical or systemic steroids or other immunosuppressants (unless discontinued before randomisation). 14. Who were on any topical antifungal agent that had been used in adequate dosage (four hourly) within the past one week 15. Who had bilateral infection

Design outcomes

Primary

MeasureTime frame
Healing of corneal ulcerTimepoint: 2, 4 & 6 weeks

Secondary

MeasureTime frame
Number of patients under going keratoplastyTimepoint: 1 week, 1 month, 6 months

Countries

India

Contacts

Public ContactDrBhupesh Bagga

L V Prasad Eye Institute

bhupesh@lvpei.org04068102615

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026