Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy - Full Text View

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

ChemIDplus related topics:

Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.

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
1: Active Comparator 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
2: Active Comparator automated lamellar keratectomy without mitomycin	Procedure: ALK (automated lamellar keratectomy) ALK is performed with a microkeratome, to make a free cap.

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

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

Keywords provided by Federal University of São Paulo:

cataract extraction

surgery

corneal disease

Study placed in the following topic categories:

Corneal Diseases

Eye Diseases

Cataract

Mitomycin

Mitomycins

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antibiotics, Antineoplastic

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00654888