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

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

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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:

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 ]

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

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.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
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
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Please refer to this study by its identifier: NCT00654888

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

Responsible Party: Eliana Domingues Gonçalves, UNIFESP Identifier: NCT00654888     History of Changes
Other Study ID Numbers: 0068/05
Study First Received: April 3, 2008
Last Updated: April 10, 2008

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

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors processed this record on April 27, 2017