OCT-guided LALAK in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Corneal Opacity

Intervention / Treatment
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* Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
* Procedure: Penetrating Keratoplasty (KP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LALAK<br> | Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)<br>* 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.<br>|
| Active Comparator: Penetrating Keratoplasty (KP)<br> | Procedure: Penetrating Keratoplasty (KP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cornea, opacity, congenital