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

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

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

Drug Information available for: 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

No publications provided

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

Anti-Bacterial Agents
Corneal Diseases
Eye Diseases
Cataract

Mitomycin
Alkylating Agents
Mitomycins

Additional relevant MeSH terms:

Corneal Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Eye Diseases
Mitomycin

Enzyme Inhibitors
Antibiotics, Antineoplastic
Alkylating Agents
Mitomycins
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009