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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
  Purpose

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 Intervention
Corneal Disease
 Procedure: ALK (automated lamellar keratectomy)
Drug: Mitomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.

Resource links provided by NLM:

Drug Information available for: Mitomycin
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain questionnaire [ Time Frame: preoperative and postoperative 1,7,30,90,180 days and one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biomicroscopy, esthesiometry, UBM pachymetry, impression cytology [ Time Frame: preoperative, postoperative 1,7,30,90,180 days and one year ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2005
Study Completion Date: February 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: automated lamellar keratectomy with PTK

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

  • herpetic endotelial disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654888

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Eliana D Gonçalves, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Eliana Domingues Gonçalves, UNIFESP
ClinicalTrials.gov Identifier: NCT00654888     History of Changes
Other Study ID Numbers: 0068/05
Study First Received: April 3, 2008
Last Updated: April 10, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
cataract extraction
surgery
corneal disease

Additional relevant MeSH terms:
Corneal Diseases
Corneal Edema
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 23, 2013