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Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

NCT ID: NCT02328053

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Mycotic Corneal Ulcer

Keywords

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fungal keratitis collagen cross linking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

collagen crosslinking group

Intervention Type PROCEDURE

collagen crosslinking with riboflavin and Ultraviolet A

Topical anti-fungal therapy

Intervention Type DRUG

topical antifungal medications like natamycin eye drops and voriconazole eye drops

standard medical therapy

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

Group Type ACTIVE_COMPARATOR

Topical anti-fungal therapy

Intervention Type DRUG

topical antifungal medications like natamycin eye drops and voriconazole eye drops

Interventions

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collagen crosslinking group

collagen crosslinking with riboflavin and Ultraviolet A

Intervention Type PROCEDURE

Topical anti-fungal therapy

topical antifungal medications like natamycin eye drops and voriconazole eye drops

Intervention Type DRUG

Other Intervention Names

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CXL, C3R natamycin, voriconazole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aravind Eye Care System

OTHER

Sponsor Role lead

Responsible Party

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Dr.N.Venkatesh Prajna

Chief Cornea Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Venkatesh Prajna, DNB,FRCS

Role: PRINCIPAL_INVESTIGATOR

CHIEF CORNEA SERVICES

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Venkatesh Prajna, DNB, FRCS

Role: CONTACT

Phone: +914524356100

Email: [email protected]

Dr. Naveen R, MBBS, MS

Role: CONTACT

Phone: +914524356100

Email: [email protected]

Facility Contacts

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Dr. Venkatesh Prajna, DNB, FRCS

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32557558 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25841317 (View on PubMed)

Other Identifiers

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IRB2013019CLI

Identifier Type: -

Identifier Source: org_study_id