search
Back to results

Deep Anterior Lamellar Keratoplasty (DALK) (DALK)

Primary Purpose

Keratoconus

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Deep anterior lamellar keratoplasty (DALK)
Penetrated keratoplasty
Sponsored by
Hospital Oftalmologico de Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring lamellar keratoplasty, keratoconus, penetrated keratoplasty, Visual acuity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Oftalmologico de Brasília

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Submitted to regular penetrating keratoplasty

Outcomes

Primary Outcome Measures

To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2009
Last Updated
April 23, 2009
Sponsor
Hospital Oftalmologico de Brasilia
search

1. Study Identification

Unique Protocol Identification Number
NCT00887900
Brief Title
Deep Anterior Lamellar Keratoplasty (DALK)
Acronym
DALK
Official Title
Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Oftalmologico de Brasilia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
lamellar keratoplasty, keratoconus, penetrated keratoplasty, Visual acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Submitted to regular penetrating keratoplasty
Intervention Type
Procedure
Intervention Name(s)
Deep anterior lamellar keratoplasty (DALK)
Other Intervention Name(s)
GROUP 1: DALK
Intervention Description
Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Intervention Type
Procedure
Intervention Name(s)
Penetrated keratoplasty
Other Intervention Name(s)
GROUP 2: PK
Intervention Description
Regular corneal transplant using the penetrated keratoplasty technique
Primary Outcome Measure Information:
Title
To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PATRICK F TZELIKIS, PhD, MD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Oftalmologico de Brasília
City
Brasília
State/Province
DF
ZIP/Postal Code
70200670
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17721317
Citation
Tan DT, Parthasarathy A. Deep anterior lamellar keratoplasty for keratoconus. Cornea. 2007 Sep;26(8):1025; author reply 1025-6. doi: 10.1097/ICO.0b013e31805771e3. No abstract available.
Results Reference
result
PubMed Identifier
17434435
Citation
Vajpayee RB, Tyagi J, Sharma N, Kumar N, Jhanji V, Titiyal JS. Deep anterior lamellar keratoplasty by big-bubble technique for treatment corneal stromal opacities. Am J Ophthalmol. 2007 Jun;143(6):954-957. doi: 10.1016/j.ajo.2007.02.036. Epub 2007 Apr 16.
Results Reference
result
PubMed Identifier
17258522
Citation
Ardjomand N, Hau S, McAlister JC, Bunce C, Galaretta D, Tuft SJ, Larkin DF. Quality of vision and graft thickness in deep anterior lamellar and penetrating corneal allografts. Am J Ophthalmol. 2007 Feb;143(2):228-235. doi: 10.1016/j.ajo.2006.10.043. Epub 2006 Nov 30.
Results Reference
result
PubMed Identifier
22331118
Citation
Tzelikis PF, Santos JD, Garcez RC, Akaishi L. [Deep anterior lamellar keratoplasty by big-bubble technique]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):435-40. doi: 10.1590/s0004-27492011000600011. Portuguese.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
PUBMED

Learn more about this trial

Deep Anterior Lamellar Keratoplasty (DALK)

We'll reach out to this number within 24 hrs