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Completed

NCT Number: NCT00887900

Deep Anterior Lamellar Keratoplasty (DALK)

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Oftalmologico de Brasília

Brasília, Federal District, 70200670, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep anterior lamellar keratoplasty (DALK)

Procedure

Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Other names: GROUP 1: DALK

Penetrated keratoplasty

Procedure

Regular corneal transplant using the penetrated keratoplasty technique

Other names: GROUP 2: PK

Primary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Oftalmologico de Brasilia

Other

Registry information

Official study title

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

Acronym: DALK

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 24, 2009
Registry last updated
Apr 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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