Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy (ALKSBK)
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.
|Corneal Disease||Procedure: ALK (automated lamellar keratectomy) Drug: Mitomycin|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.|
- 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 ]
|Study Start Date:||March 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
mitomycin 0,02%, 30 seconds after ALK
Other Name: automated lamellar keratectomy associated with PTK
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 Name: automated lamellar keratectomy with PTK
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654888
|Principal Investigator:||Eliana D Gonçalves, MD||Federal University of São Paulo|