Corneal Opacity
Conditions
Keywords
cornea, opacity, congenital
Brief 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).
Detailed 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.
Interventions
PROCEDUREOCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
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.
PROCEDUREPenetrating Keratoplasty (KP)
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.
Sponsors
National Institutes of Health (NIH)
National Eye Institute (NEI)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of LALAK patients with post operative complications compared to PK patients | 24 months | Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable). |
Countries
United States
Outcome results
None listed