Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Not Applicable

Completed

• Conditions: Corneal Disease
• Interventions: Procedure: ALK (automated lamellar keratectomy); Drug: Mitomycin

• Registration Number: NCT00654888
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2006-03
• Study Completion: 2008-02
• Status Verified: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patient with bullous keratopathy symptomatic (with pain)

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Exclusion Criteria

• herpetic endotelial disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ALK (automated lamellar keratectomy)	automated lamellar keratectomy without mitomycin
1	Mitomycin	Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).

Primary Outcome Measures

Name	Time	Method
Pain questionnaire	preoperative and postoperative 1,7,30,90,180 days and one year

Secondary Outcome Measures

Name	Time	Method
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology	preoperative, postoperative 1,7,30,90,180 days and one year