Automated Lamellar Keratectomy in Symptomatic Patients Wi... | NCT00654888

Studies
Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

NCT00654888

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Apr 11, 2008Estimated

Enrollment

28Actual

Phase

Not Applicable

Conditions

Corneal Disease

Interventions

ALK (automated lamellar keratectomy)
Mitomycin

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

Apr 2008

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

Mar 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Feb 2008Actual

First Submitted Date

Apr 3, 2008

First Submission Date that Met QC Criteria

Apr 3, 2008

First Posted Date

Apr 9, 2008Estimated

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

Apr 10, 2008

Last Update Posted Date

Apr 11, 2008Estimated

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

To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.

The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.

Detailed Description

Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).

Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).	Drug: Mitomycin
2	Active Comparator	automated lamellar keratectomy without mitomycin	Procedure: ALK (automated lamellar keratectomy)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALK (automated lamellar keratectomy)	Procedure	ALK is performed with a microkeratome, to make a free cap.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain questionnaire		preoperative and postoperative 1,7,30,90,180 days and one year

Secondary Outcomes

Measure	Description	Time Frame
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology		preoperative, postoperative 1,7,30,90,180 days and one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

herpetic endotelial disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eliana D Gonçalves, MD	Federal University of São Paulo	Principal Investigator

Locations

Not provided

ID	Term
D003316	Corneal Diseases

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D016685	Mitomycin

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided