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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Eye Institute (NEI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LALAK | Experimental |
| |
| Penetrating Keratoplasty (KP) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) | Procedure |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bibiana Reiser, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D003318 | Corneal Opacity |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015948 | Keratoplasty, Penetrating |
| ID | Term |
|---|---|
| D016039 | Corneal Transplantation |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
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|
| Penetrating Keratoplasty (KP) | Procedure |
|
|
| D013812 | Therapeutics |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |