Customized PRK With Mitomycin Versus Customized Lasik for... | NCT00365040

Studies
Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

NCT00365040

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Aug 17, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Refractive Errors

Interventions

Prk with mitomycin vs Lasik

Countries

Not provided

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 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Aug 15, 2006

First Submission Date that Met QC Criteria

Aug 15, 2006

First Posted Date

Aug 17, 2006Estimated

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 15, 2006

Last Update Posted Date

Aug 17, 2006Estimated

Description Module

Brief Summary

The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Prk with mitomycin vs Lasik	Procedure

Measure	Description	Time Frame
subjective evaluation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease

Exclusion Criteria:

Diabetes, autoimmune diseases, topographic abnormalities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mauro Campos, MD	Federal University of São Paulo	Study Chair

ID	Term
D012030	Refractive Errors
D009216	Myopia

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D018903	Photorefractive Keratectomy

Ancestor Terms

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
visual acuity
refractive errors
topography patterns
aberrometry data