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Deep Anterior Lamellar Keratoplasty (DALK) (DALK)

This study has been completed.
Information provided by:
Hospital Oftalmologico de Brasilia Identifier:
First received: April 23, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Condition Intervention Phase
Procedure: Deep anterior lamellar keratoplasty (DALK)
Procedure: Penetrated keratoplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications

Resource links provided by NLM:

Further study details as provided by Hospital Oftalmologico de Brasilia:

Primary Outcome Measures:
  • To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. [ Time Frame: 12 months ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • keratoconus

Exclusion Criteria:

  • central endothelial cell count less than 2000 cells/mm2
  • glaucoma or intraocular pressure greater than 21 mmHg
  • amblyopia
  • retinal abnormalities
  • diabetes mellitus
  • steroid or immunosuppressive treatment
  • connective tissue diseases
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Please refer to this study by its identifier: NCT00887900

Hospital Oftalmologico de Brasília
Brasília, DF, Brazil, 70200670
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
Principal Investigator: PATRICK F TZELIKIS, PhD, MD Federal University of Minas Gerais
  More Information

Additional Information:
PUBMED  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PATRICK TZELIKIS, HOB Identifier: NCT00887900     History of Changes
Other Study ID Numbers: DALK
Study First Received: April 23, 2009
Last Updated: April 23, 2009

Keywords provided by Hospital Oftalmologico de Brasilia:
lamellar keratoplasty
penetrated keratoplasty
Visual acuity

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases processed this record on May 25, 2017