An interventional study of ALK (automated lamellar keratectomy) and Mitomycin in Corneal Disease, sponsored by Federal University of São Paulo. Completed. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2008-04-11.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
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.
130 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's enrollment of 28 is below the median of 32 across 78 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
Drug: Mitomycin
automated lamellar keratectomy without mitomycin
Procedure: ALK (automated lamellar keratectomy)
ALK is performed with a microkeratome, to make a free cap.
Also known as: automated lamellar keratectomy with PTK
mitomycin 0,02%, 30 seconds after ALK
Also known as: automated lamellar keratectomy associated with PTK
Pain questionnaire
Time frame: preoperative and postoperative 1,7,30,90,180 days and one year
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
Time frame: preoperative, postoperative 1,7,30,90,180 days and one year
No study locations are listed for this record.
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo