UVX as an Adjuvant in the Treatment of Fungal Keratitis

NCT ID: NCT03138785

Last Updated: 2017-05-03

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

2015-01-01

Study Completion Date

2017-07-01

Brief Summary

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In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis

Detailed Description

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Conditions

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional treatment

In this arm, patients with documented fungal keratitis undergo conventional medical treatment.

Group Type EXPERIMENTAL

topical voriconazole / levofloxacin systemic itraconazole

Intervention Type DRUG

starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks

conventional treatment +CXL

In this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day

Group Type ACTIVE_COMPARATOR

topical voriconazole / levofloxacin systemic itraconazole

Intervention Type DRUG

starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks

CXL

Intervention Type RADIATION

30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration

Interventions

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topical voriconazole / levofloxacin systemic itraconazole

starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks

Intervention Type DRUG

CXL

30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration

Intervention Type RADIATION

Other Intervention Names

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Collagen cross-linking/ UVx

Eligibility Criteria

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Inclusion Criteria

* fungal keratitis documented by culture or confocal scanning without any previous treatment

Exclusion Criteria

* Previous treatment
* Thinning at presentation
* Perforation
* Associated with other microbial or viral keratitis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farabi Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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mohammad soleimani

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Other Identifiers

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32768

Identifier Type: -

Identifier Source: org_study_id

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