OCT-guided LALAK in Children

NCT ID: NCT01579643

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Corneal Opacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LALAK

Group Type: EXPERIMENTAL

OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)

Intervention Type: PROCEDURE

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.

Penetrating Keratoplasty (KP)

Group Type: ACTIVE_COMPARATOR

Penetrating Keratoplasty (KP)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bibiana Reiser, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

OHSU IRB#00006612 LALAK Child

Identifier Type: -

Identifier Source: org_study_id