Deep Anterior Lamellar Keratoplasty (DALK)

This study has been completed.
Sponsor:
Information provided by:
Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier:
NCT00887900
First received: April 23, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: April 23, 2009
Last Updated: April 23, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014