OCT-guided LALAK in Children
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2018 |
| First Submitted: | 01/02/2012 |
| Estimated Enrollment Submitted: | 04/15/2012 |
| First Posted: | 04/17/2012 |
| Last Update Submitted: | 04/11/2018 |
| Last Update Posted: | 04/16/2018 |
| Actual Study Start Date: | 12/31/2011 |
| Estimated Primary Completion Date: | 08/30/2016 |
| Estimated Study Completion Date: | 08/30/2016 |
Condition or disease
Intervention/treatment
Procedure: LALAK
Procedure: Penetrating Keratoplasty (KP)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: LALAK | Procedure: 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. |
Eligibility Criteria
| Ages Eligible for Study | 1 Month To 1 Month |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Number of LALAK patients with post operative complications compared to PK patients [24 months]
