NCT00365040

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 17, 2006

Status Verified

July 1, 2006

First QC Date

August 15, 2006

Last Update Submit

August 15, 2006

Conditions

Refractive Errors

Keywords

myopiaexcimer laser

Outcome Measures

Primary Outcomes (4)

  • visual acuity

  • refractive errors

  • topography patterns

  • aberrometry data

Secondary Outcomes (1)

  • subjective evaluation

Interventions

Prk with mitomycin vs LasikPROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes, autoimmune diseases, topographic abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refractive ErrorsMyopia

Interventions

Photorefractive Keratectomy

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Mauro Campos, MD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

December 1, 2004

Study Completion

October 1, 2006

Last Updated

August 17, 2006

Record last verified: 2006-07