Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02328053

Enrollment

Registered

2014-12-31

Start date

2014-02-28

Completion date

2015-09-30

Last updated

2014-12-31

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

Conditions

Mycotic Corneal Ulcer

Keywords

fungal keratitis, collagen cross linking

Brief summary

The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.

Detailed description

Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.

Interventions

PROCEDUREcollagen crosslinking group

collagen crosslinking with riboflavin and Ultraviolet A

DRUGTopical anti-fungal therapy

topical antifungal medications like natamycin eye drops and voriconazole eye drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Ulcer size more than 5 mm * Ulcer depth upto 70% of stromal depth * Corneal thickness of 400 microns and above

Exclusion criteria

* Corneal thickness of below 400 microns * Ulcers involving the limbus * Pregnant women * Children below the age of 18 years

Design outcomes

Primary

Measure	Time frame
size of infiltrate or scar, corneal structural integrity	6 months

Secondary

Measure	Time frame
visual acuity	6 months

Countries

India

Contacts

Primary ContactDr. Venkatesh Prajna, DNB, FRCS

mutt@aravind.org+914524356100

Backup ContactDr. Naveen R, MBBS, MS

naveenmogana@gmail.com+914524356100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026