OCT-guided LALAK in Children

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Corneal Opacity	Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) Procedure: Penetrating Keratoplasty (KP)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1 participants

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 31, 2016

Actual Study Completion Date :

Aug 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LALAK	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.
Active Comparator: Penetrating Keratoplasty (KP)	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.

Arm

Intervention/Treatment

Experimental: LALAK

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.

Active Comparator: Penetrating Keratoplasty (KP)

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Huang, Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT01579643

Other Study ID Numbers:

OHSU IRB#00006612 LALAK Child

First Posted:

Apr 18, 2012

Last Update Posted:

Apr 17, 2018

Last Verified:

Apr 1, 2018

Keywords provided by David Huang, Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology, Children's Hospital Los Angeles

cornea

opacity

congenital

Additional relevant MeSH terms:

Corneal Opacity

Study Results

No Results Posted as of Apr 17, 2018