OCT-guided LALAK in Children (LALAK)
|ClinicalTrials.gov Identifier: NCT01579643|
Recruitment Status : Unknown
Verified April 2015 by David Huang, Children's Hospital Los Angeles.
Recruitment status was: Recruiting
First Posted : April 18, 2012
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment|
|Corneal Opacity||Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) Procedure: Penetrating Keratoplasty (KP)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
|Active Comparator: Penetrating Keratoplasty (KP)||
Procedure: Penetrating Keratoplasty (KP)
- Number of LALAK patients with post operative complications compared to PK patients [ Time Frame: 24 months ]Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579643
|Contact: Cassandra Fink||(323) 361-2265||CFink@chla.usc.edu|
|United States, California|
|Children's Hospital of Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Cassandra Fink 323-361-2265 CFink@chla.usc.edu|
|Principal Investigator: Bibiana Reiser, MD|
|Principal Investigator:||Bibiana Reiser, MD||Children's Hospital Los Angeles|