Phototherapeutic Keratectomy (PTK) With Mitomycin in Aden... | NCT00492245

Studies
Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

NCT00492245

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Aug 4, 2008Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Keratitis
Corneal Opacity

Interventions

PTK with mitomycin in Adenoviral Opacities

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

May 2008

Completion Date

Dec 2008Estimated

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 26, 2007

First Posted Date

Jun 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2008

Last Update Posted Date

Aug 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
PTK with mitomycin in Adenoviral Opacities	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.		one year

Secondary Outcomes

Measure	Description	Time Frame
wavefront analysis, anterior segment tomography data, corneal biomechanics data.		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ester S Yamazaki, MD	Federal University of Sao Paulo - Brazil	Principal Investigator
Mauro S Campos, MD	Federal University of Sao Paulo - Brazil	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Sao Paulo		São Paulo	São Paulo	04145020	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12631015	Background	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.
12553604	Background	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.

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

ID	Term
D007634	Keratitis
D003318	Corneal Opacity