Deep Anterior Lamellar Keratoplasty (DALK) (DALK)
|ClinicalTrials.gov Identifier: NCT00887900|
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : April 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Procedure: Deep anterior lamellar keratoplasty (DALK) Procedure: Penetrated keratoplasty||Phase 3|
Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Methods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2008|
Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Procedure: Deep anterior lamellar keratoplasty (DALK)
Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Other Name: GROUP 1: DALK
Active Comparator: 2
Submitted to regular penetrating keratoplasty
Procedure: Penetrated keratoplasty
Regular corneal transplant using the penetrated keratoplasty technique
Other Name: GROUP 2: PK
- To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887900
|Hospital Oftalmologico de Brasília|
|Brasília, DF, Brazil, 70200670|
|Principal Investigator:||PATRICK F TZELIKIS, PhD, MD||Federal University of Minas Gerais|