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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00654888
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 9, 2008
Last Update Posted Date April 11, 2008
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Pain questionnaire [ Time Frame: preoperative and postoperative 1,7,30,90,180 days and one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology [ Time Frame: preoperative, postoperative 1,7,30,90,180 days and one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
Official Title  ICMJE Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Corneal Disease
Intervention  ICMJE
  • Procedure: ALK (automated lamellar keratectomy)
    ALK is performed with a microkeratome, to make a free cap.
    Other Name: automated lamellar keratectomy with PTK
  • Drug: Mitomycin
    mitomycin 0,02%, 30 seconds after ALK
    Other Name: automated lamellar keratectomy associated with PTK
Study Arms  ICMJE
  • Active Comparator: 1
    Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
    Intervention: Drug: Mitomycin
  • Active Comparator: 2
    automated lamellar keratectomy without mitomycin
    Intervention: Procedure: ALK (automated lamellar keratectomy)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

  • herpetic endotelial disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00654888
Other Study ID Numbers  ICMJE 0068/05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eliana Domingues Gonçalves, UNIFESP
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eliana D Gonçalves, MD Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP