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Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy (ALKSBK)

Primary Purpose

Corneal Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ALK (automated lamellar keratectomy)
Mitomycin
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Disease focused on measuring cataract extraction, surgery, corneal disease

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

  • herpetic endotelial disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).

    automated lamellar keratectomy without mitomycin

    Outcomes

    Primary Outcome Measures

    Pain questionnaire

    Secondary Outcome Measures

    biomicroscopy, esthesiometry, UBM pachymetry, impression cytology

    Full Information

    First Posted
    April 3, 2008
    Last Updated
    April 10, 2008
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00654888
    Brief Title
    Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
    Acronym
    ALKSBK
    Official Title
    Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Disease
    Keywords
    cataract extraction, surgery, corneal disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    automated lamellar keratectomy without mitomycin
    Intervention Type
    Procedure
    Intervention Name(s)
    ALK (automated lamellar keratectomy)
    Other Intervention Name(s)
    automated lamellar keratectomy with PTK
    Intervention Description
    ALK is performed with a microkeratome, to make a free cap.
    Intervention Type
    Drug
    Intervention Name(s)
    Mitomycin
    Other Intervention Name(s)
    automated lamellar keratectomy associated with PTK
    Intervention Description
    mitomycin 0,02%, 30 seconds after ALK
    Primary Outcome Measure Information:
    Title
    Pain questionnaire
    Time Frame
    preoperative and postoperative 1,7,30,90,180 days and one year
    Secondary Outcome Measure Information:
    Title
    biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
    Time Frame
    preoperative, postoperative 1,7,30,90,180 days and one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with bullous keratopathy symptomatic (with pain) Exclusion Criteria: herpetic endotelial disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eliana D Gonçalves, MD
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

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