ALKSBK: Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00654888
Collaborator
(none)
28
2
35.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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

Drug: Mitomycin
mitomycin 0,02%, 30 seconds after ALK
Other Names:
  • automated lamellar keratectomy associated with PTK
  • Active Comparator: 2

    automated lamellar keratectomy without mitomycin

    Procedure: ALK (automated lamellar keratectomy)
    ALK is performed with a microkeratome, to make a free cap.
    Other Names:
  • automated lamellar keratectomy with PTK
  • Outcome Measures

    Primary Outcome Measures

    1. Pain questionnaire [preoperative and postoperative 1,7,30,90,180 days and one year]

    Secondary Outcome Measures

    1. biomicroscopy, esthesiometry, UBM pachymetry, impression cytology [preoperative, postoperative 1,7,30,90,180 days and one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with bullous keratopathy symptomatic (with pain)
    Exclusion Criteria:
    • herpetic endotelial disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    • Principal Investigator: Eliana D Gonçalves, MD, Federal University of São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00654888
    Other Study ID Numbers:
    • 0068/05
    First Posted:
    Apr 9, 2008
    Last Update Posted:
    Apr 11, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2008