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OCT-guided LALAK in Children (LALAK)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by David Huang, Children's Hospital Los Angeles.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579643
First Posted: April 18, 2012
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Children's Hospital Los Angeles
  Purpose
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).

Condition Intervention
Corneal Opacity Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) Procedure: Penetrating Keratoplasty (KP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children

Further study details as provided by David Huang, Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Number of LALAK patients with post operative complications compared to PK patients [ Time Frame: 24 months ]
    Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).


Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LALAK 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.
Active Comparator: Penetrating Keratoplasty (KP) 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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579643


Contacts
Contact: Cassandra Fink (323) 361-2265 CFink@chla.usc.edu

Locations
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Cassandra Fink    323-361-2265    CFink@chla.usc.edu   
Principal Investigator: Bibiana Reiser, MD         
Sponsors and Collaborators
Oregon Health and Science University
National Institutes of Health (NIH)
National Eye Institute (NEI)
Investigators
Principal Investigator: Bibiana Reiser, MD Children's Hospital Los Angeles
  More Information

Responsible Party: David Huang, Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01579643     History of Changes
Other Study ID Numbers: OHSU IRB#00006612 LALAK Child
First Submitted: January 3, 2012
First Posted: April 18, 2012
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by David Huang, Children's Hospital Los Angeles:
cornea
opacity
congenital

Additional relevant MeSH terms:
Corneal Opacity
Corneal Diseases
Eye Diseases