CClinicalTrials.gg
Status unknownNCT02328053Updated Dec 31, 2014

Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

An interventional study of collagen crosslinking group and Topical anti-fungal therapy in Mycotic Corneal Ulcer, sponsored by Aravind Eye Care System. Status unknown at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-31.

Sponsored by Aravind Eye Care System · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mycotic Corneal Ulcer

Keywords

  • fungal keratitis
  • collagen cross linking
03

In context

Corneal Ulcer

57 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 45 interventional studies indexed under Corneal Ulcer.

Browse Corneal Ulcer studies →

Lead sponsor

Aravind Eye Care System is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Collagen crosslinking group

    patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy

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

  • Active comparator
    standard medical therapy

    patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops

    Drug: Topical anti-fungal therapy

Interventions

  • Procedurecollagen crosslinking group

    collagen crosslinking with riboflavin and Ultraviolet A

    Also known as: CXL, C3R

  • DrugTopical anti-fungal therapy

    topical antifungal medications like natamycin eye drops and voriconazole eye drops

    Also known as: natamycin, voriconazole

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What researchers measure

Primary outcomes

  1. size of infiltrate or scar, corneal structural integrity

    Time frame: 6 months

Secondary outcomes

  1. visual acuity

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Aravind Eye Hospital
    Madurai, Tamilnadu 624002, India
    Recruiting
08

References and documents

Publications

  • Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2. PubMed 32557558 ↗
  • Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1. PubMed 25841317 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02328053
Lead sponsor
Aravind Eye Care System
Responsible party
Dr.N.Venkatesh Prajna (Chief Cornea Services, Aravind Eye Care System) — Principal investigator
First posted
Dec 31, 2014
Start date
Feb 2014
Primary completion
Jul 2015 (estimated)
Completion
Sep 2015 (estimated)
Last update
Dec 31, 2014

Study contacts

Dr. Venkatesh Prajna, DNB, FRCS
Contact
mutt@aravind.org
+914524356100
Dr. Naveen R, MBBS, MS
Contact
naveenmogana@gmail.com
+914524356100
Dr. Venkatesh Prajna, DNB,FRCS
principal investigator · CHIEF CORNEA SERVICES

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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