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Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

NCT ID: NCT00492245

Last Updated: 2008-08-04

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Detailed Description

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Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

Conditions

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Keratitis Corneal Opacity

Keywords

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PTK corneal opacity mitomycin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PTK with mitomycin in Adenoviral Opacities

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* visual acuity worse than 20/40, caused by central subepithelial fibrosis

Exclusion Criteria

* pregnancy, age less than 18 years-old or more than 80 years-old.
* diabetes, autoimmune diseases, corneal thickness less tha 400 micron.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Ester S Yamazaki, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Sao Paulo - Brazil

Mauro S Campos, MD

Role: STUDY_CHAIR

Federal University of Sao Paulo - Brazil

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x.

Reference Type BACKGROUND
PMID: 12631015 (View on PubMed)

Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08.

Reference Type BACKGROUND
PMID: 12553604 (View on PubMed)

Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20.

Reference Type BACKGROUND
PMID: 17307254 (View on PubMed)

Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24.

Reference Type DERIVED
PMID: 21109229 (View on PubMed)

Other Identifiers

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CEP0075/06

Identifier Type: -

Identifier Source: org_study_id