OCT-guided LALAK in Children
Status
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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