OCT-guided LALAK in Children

Not Applicable

Terminated

• Conditions: Corneal Opacity
• Interventions: Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK); Procedure: Penetrating Keratoplasty (KP)

• Registration Number: NCT01579643
• Lead Sponsor: Oregon Health and Science University

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 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LALAK	OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)	-
Penetrating Keratoplasty (KP)	Penetrating Keratoplasty (KP)	-

Primary Outcome Measures

Name	Time	Method
Number of LALAK patients with post operative complications compared to PK patients	24 months	Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).

Trial Locations

Locations (1)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States