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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00654888
First received: April 3, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes

April 3, 2008
April 10, 2008
March 2005
March 2006   (final data collection date for primary outcome measure)
Pain questionnaire [ Time Frame: preoperative and postoperative 1,7,30,90,180 days and one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00654888 on ClinicalTrials.gov Archive Site
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology [ Time Frame: preoperative, postoperative 1,7,30,90,180 days and one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Corneal Disease
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2008
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

  • herpetic endotelial disorders
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00654888
0068/05
Yes
Eliana Domingues Gonçalves, UNIFESP
Federal University of São Paulo
Not Provided
Principal Investigator: Eliana D Gonçalves, MD Federal University of São Paulo
Federal University of São Paulo
April 2008

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