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Deep Anterior Lamellar Keratoplasty (DALK) (DALK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00887900
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : April 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Deep anterior lamellar keratoplasty (DALK) Procedure: Penetrated keratoplasty Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications
Study Start Date : January 2006
Primary Completion Date : December 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00887900


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

Additional Information:
PUBMED  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PATRICK TZELIKIS, HOB
ClinicalTrials.gov Identifier: NCT00887900     History of Changes
Other Study ID Numbers: DALK
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: April 24, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases