Study on the Effect of Mitomycin C 0.02% on the Corneal E... | NCT00999973

Studies
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

NCT00999973

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Oct 22, 2009Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Myopia

Interventions

Mitomycin C 0.02%
Placebo

Countries

Iran

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 21, 2009

First Posted Date

Oct 22, 2009Estimated

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

Oct 21, 2009

Last Update Posted Date

Oct 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.

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

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitomycin c 0.02%	Active Comparator		Drug: Mitomycin C 0.02%
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitomycin C 0.02%	Drug		Mitomycin c 0.02%
Placebo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

19 < age < 60
Refractory error stabled for at least one year
No corneal pathology
-3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes

Exclusion criteria:

Keratoconus
Ectatic corneal disease
Glaucoma
Corneal dystrophy
Lens changes affecting the visual acuity
Anterior or posterior uveitis
Corneal scar

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Ali Javadi, MD	Contact	+982122585952		labbafi@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Center	Recruiting	Tehran		166666	Iran

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases