Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy (ALKSBK)
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|ClinicalTrials.gov Identifier: NCT00654888|
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 11, 2008
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|
|Corneal Disease||Procedure: ALK (automated lamellar keratectomy) Drug: Mitomycin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||February 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654888
|Principal Investigator:||Eliana D Gonçalves, MD||Federal University of São Paulo|