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NCT00887900 Clinical Trial

Deep Anterior Lamellar Keratoplasty (DALK)

Keratoconus Clinical Trial

— DALK  

Official title:
Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00887900
Other study ID # DALK
Secondary ID
Status Completed
Phase Phase 3
First received April 23, 2009
Last updated April 23, 2009
Start date January 2006
Est. completion date December 2008

Study information
Verified date April 2009
Source Hospital Oftalmologico de Brasilia
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Deep anterior lamellar keratoplasty (DALK)
Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
• Penetrated keratoplasty
Regular corneal transplant using the penetrated keratoplasty technique

Locations
Country Name City State
Brazil Hospital Oftalmologico de Brasília Brasília DF

Sponsors (1)
Lead Sponsor Collaborator
Hospital Oftalmologico de Brasilia

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Epub 2006 Nov 30. — View Citation

Tan DT, Parthasarathy A. Deep anterior lamellar keratoplasty for keratoconus. Cornea. 2007 Sep;26(8):1025; author reply 1025-6. — View 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. Epub 2007 Apr 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. 12 months Yes
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