OCT-guided LALAK in Children
LALAK
Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
1 other identifier
interventional
1
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2016
CompletedApril 17, 2018
April 1, 2018
4.7 years
January 3, 2012
April 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
LALAK
EXPERIMENTALPenetrating Keratoplasty (KP)
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- National Institutes of Health (NIH)collaborator
- National Eye Institute (NEI)collaborator
Study Sites (1)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bibiana Reiser, MD
Children's Hospital Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology
Study Record Dates
First Submitted
January 3, 2012
First Posted
April 18, 2012
Study Start
January 1, 2012
Primary Completion
August 31, 2016
Study Completion
August 31, 2016
Last Updated
April 17, 2018
Record last verified: 2018-04