ALKSBK: Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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 Names:
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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 Names:
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Outcome Measures
Primary Outcome Measures
- Pain questionnaire [preoperative and postoperative 1,7,30,90,180 days and one year]
Secondary Outcome Measures
- biomicroscopy, esthesiometry, UBM pachymetry, impression cytology [preoperative, postoperative 1,7,30,90,180 days and one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient with bullous keratopathy symptomatic (with pain)
Exclusion Criteria:
- herpetic endotelial disorders
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Federal University of São Paulo
Investigators
- Principal Investigator: Eliana D Gonçalves, MD, Federal University of São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0068/05