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Deep Anterior Lamellar Keratoplasty (DALK)

Phase 3
Completed
Conditions
Keratoconus
Interventions
Procedure: Deep anterior lamellar keratoplasty (DALK)
Procedure: Penetrated keratoplasty
Registration Number
NCT00887900
Lead Sponsor
Hospital Oftalmologico de Brasilia
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Deep anterior lamellar keratoplasty (DALK)Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
2Penetrated keratoplastySubmitted to regular penetrating keratoplasty
Primary Outcome Measures
NameTimeMethod
To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.12 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hospital Oftalmologico de Brasília

🇧🇷

Brasília, DF, Brazil

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