An interventional study of OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) and Penetrating Keratoplasty (KP) in Corneal Opacity, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
Procedure: Penetrating Keratoplasty (KP)
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.
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.
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).
Time frame: 24 months
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University