OCT-guided LALAK in Children

This study is currently recruiting participants.

Verified April 2012 by Oregon Health and Science University

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Eye Institute (NEI)

Information provided by (Responsible Party):

David Huang, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT01579643

First received: January 3, 2012

Last updated: April 24, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2012

Last Updated Date

April 24, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

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).

Change History

Complete list of historical versions of study NCT01579643 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

OCT-guided LALAK in Children

Official Title ^ICMJE

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 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 complicatons.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Corneal Opacity

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: LALAK
Intervention: Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
Active Comparator: Penetrating Keratoplasty (KP)
Intervention: Procedure: Penetrating Keratoplasty (KP)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

1 Month to 7 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Cassandra Fink

(323) 361-2265

CFink@chla.usc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01579643

Other Study ID Numbers ^ICMJE

OHSU IRB#00006612 LALAK Child

Has Data Monitoring Committee

Yes

Responsible Party

David Huang, Children's Hospital Los Angeles

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

National Institutes of Health (NIH)
National Eye Institute (NEI)

Investigators ^ICMJE

Principal Investigator:

Bibiana Reiser, MD

Children's Hospital Los Angeles

Information Provided By

Oregon Health and Science University

Verification Date

April 2012

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

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