OCT-guided LALAK in Children

Overview

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).

Full Title of Study: “Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2016

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.

Interventions

  • Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
    • 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. The host cornea bed will be prepared with an excimer laser. Descemet’s membrane will be peeled off the graft, and the graft sutured into the host bed.
  • Procedure: Penetrating Keratoplasty (KP)
    • 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. The donor cornea is then sutured where the patient’s cornea was.

Arms, Groups and Cohorts

  • Experimental: LALAK
  • Active Comparator: Penetrating Keratoplasty (KP)

Clinical Trial Outcome Measures

Primary 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Huang, Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology – Children’s Hospital Los Angeles
  • Overall Official(s)
    • Bibiana Reiser, MD, Principal Investigator, Children’s Hospital Los Angeles

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.