OCT-guided LALAK in Children

Corneal Opacity Clinical Trial

— LALAK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01579643
• Other study ID #: OHSU IRB#00006612 LALAK Child
• Status: Terminated
• Phase: N/A
• First received: January 3, 2012
• Last updated: April 12, 2018
• Start date: January 2012
• Est. completion date: August 31, 2016

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Opacity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of LALAK patients with post operative complications compared to PK patients	Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).	24 months