NCT00887900

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
Last Updated

April 24, 2009

Status Verified

April 1, 2009

Enrollment Period

1.9 years

First QC Date

April 23, 2009

Last Update Submit

April 23, 2009

Conditions

Keratoconus

Keywords

lamellar keratoplastykeratoconuspenetrated keratoplastyVisual acuity

Outcome Measures

Primary Outcomes (1)

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

    12 months

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: Deep anterior lamellar keratoplasty (DALK)

2

ACTIVE COMPARATOR

Submitted to regular penetrating keratoplasty

Procedure: Penetrated keratoplasty

Interventions

Deep anterior lamellar keratoplasty (DALK)PROCEDURE

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

Also known as: GROUP 1: DALK
1
Penetrated keratoplastyPROCEDURE

Regular corneal transplant using the penetrated keratoplasty technique

Also known as: GROUP 2: PK
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • keratoconus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Oftalmologico de Brasília

Brasília, Federal District, 70200670, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 17721317RESULT

  • 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.

    PMID: 17434435RESULT

  • 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.

    PMID: 17258522RESULT

  • 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.

    PMID: 22331118DERIVED

Related Links

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • PATRICK F TZELIKIS, PhD, MD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

April 24, 2009

Record last verified: 2009-04

Locations

BR(1)