Deep Anterior Lamellar Keratoplasty (DALK)

Hospital Oftalmologico de Brasilia

Status and phase: Completed; Phase 3

Conditions: Keratoconus

Treatments: Procedure: Deep anterior lamellar keratoplasty (DALK); Procedure: Penetrated keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00887900

DALK

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Procedure: Deep anterior lamellar keratoplasty (DALK)

2

Active Comparator group

Description:

Submitted to regular penetrating keratoplasty

Treatment:

Procedure: Penetrated keratoplasty