NCT00654888

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

April 3, 2008

Last Update Submit

April 10, 2008

Conditions

Corneal Disease

Keywords

cataract extractionsurgerycorneal disease

Outcome Measures

Primary Outcomes (1)

  • Pain questionnaire

    preoperative and postoperative 1,7,30,90,180 days and one year

Secondary Outcomes (1)

  • biomicroscopy, esthesiometry, UBM pachymetry, impression cytology

    preoperative, postoperative 1,7,30,90,180 days and one year

Study Arms (2)

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

ALK (automated lamellar keratectomy)PROCEDURE

ALK is performed with a microkeratome, to make a free cap.

Also known as: automated lamellar keratectomy with PTK
2
MitomycinDRUG

mitomycin 0,02%, 30 seconds after ALK

Also known as: automated lamellar keratectomy associated with PTK
1

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with bullous keratopathy symptomatic (with pain)

You may not qualify if:

  • herpetic endotelial disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Diseases

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eliana D Gonçalves, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

February 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04