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Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

A

Aravind Eye Care System

Status

Unknown

Conditions

Mycotic Corneal Ulcer

Treatments

Procedure: collagen crosslinking group
Drug: Topical anti-fungal therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02328053
IRB2013019CLI

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Collagen crosslinking group
Experimental group
Description:
patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy
Treatment:
Drug: Topical anti-fungal therapy
Procedure: collagen crosslinking group
standard medical therapy
Active Comparator group
Description:
patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
Treatment:
Drug: Topical anti-fungal therapy

Trial contacts and locations

1

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Central trial contact

Dr. Venkatesh Prajna, DNB, FRCS; Dr. Naveen R, MBBS, MS

Data sourced from clinicaltrials.gov

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