Clinical Trial: OCT-guided LALAK in Children

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children

Brief Summary: 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).

Detailed Summary:

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.

Sponsor: Oregon Health and Science University

Current Primary Outcome: Number of LALAK patients with post operative complications compared to PK patients [ Time Frame: 24 months ]

Original Primary Outcome: Does LALAK have fewer post-operative complications than PK [ Time Frame: 24 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: January 3, 2012
Date Started: January 2012
Date Completion: January 2016
Last Updated: April 21, 2015
Last Verified: April 2015