OCT-guided LALAK in Children

This study is currently recruiting participants.
Verified April 2014 by Oregon Health and Science University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
David Huang, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01579643
First received: January 3, 2012
Last updated: April 7, 2014
Last verified: April 2014

January 3, 2012
April 7, 2014
January 2012
January 2016   (final data collection date for primary outcome measure)
Number of LALAK patients with post operative complications compared to PK patients [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
Does LALAK have fewer post-operative complications than PK [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
Complete list of historical versions of study NCT01579643 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
OCT-guided LALAK in Children
Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children

The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).

There is a great need for lamellar keratectomy in the treatment of congenital opacities because the rejection rate in pediatric PK is 4-5 times higher than in adults. In addition, the intraocular inflammatory reaction in infants often leads to synechiae, glaucoma, and cataract. Because LALAK does not penetrate the eye and preserves the host endothelium, it could reduce the risk of these complications. Keratoplasty must be performed at this early age to prevent amblyopia.

In this study, OCT-guided LALAK will be performed in patients whose vision is limited by opacity in the anterior 2/3 of the cornea. The objective is to determine if LALAK will provide an equal or better visual outcome than traditional PK without the associated post-operative complications.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Opacity
  • Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
    1. The top hat-shaped donor cornea graft with tapered brim will be cut using a femtosecond (fs) laser at the eye bank. An anterior diameter of 6.0 mm will be used. The depth of the anterior side cut will match the planned excimer ablation depth.
    2. The host cornea bed will be prepared with an excimer laser.
    3. Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed.
  • Procedure: Penetrating Keratoplasty (KP)
    1. A trephine is used to perform a full thickness cut of a round area of cornea from the both patient's and donor's cornea.
    2. The donor cornea is then sutured where the patient's cornea was.
  • Experimental: LALAK
    Intervention: Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
  • Active Comparator: Penetrating Keratoplasty (KP)
    Intervention: Procedure: Penetrating Keratoplasty (KP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Vision limited by opacity in the anterior 2/3 of the corneal stroma
  • Posterior opacity and endothelial defect must be less than 1 mm in diameter

Exclusion Criteria:

  • Presence of cataract
  • Presence of adhesions of the iris or lens to the cornea
  • Inability/unwillingness of parents to give informed consent
  • Inability of parents to commit to required visits to complete the study
Both
1 Month to 18 Years
No
Contact: Cassandra Fink (323) 361-2265 CFink@chla.usc.edu
United States
 
NCT01579643
OHSU IRB#00006612 LALAK Child
Yes
David Huang, Children's Hospital Los Angeles
Oregon Health and Science University
  • National Institutes of Health (NIH)
  • National Eye Institute (NEI)
Principal Investigator: Bibiana Reiser, MD Children's Hospital Los Angeles
Oregon Health and Science University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP