Back to resultsOCT-guided LALAK in Children (LALAK)
Primary Purpose
Corneal Opacity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
Penetrating Keratoplasty (KP)
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Opacity focused on measuring cornea, opacity, congenital
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LALAK
Penetrating Keratoplasty (KP)
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01579643
First Posted
January 3, 2012
Last Updated
April 12, 2018
Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT01579643
Brief Title
OCT-guided LALAK in Children
Acronym
LALAK
Official Title
Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Opacity
Keywords
cornea, opacity, congenital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LALAK
Arm Type
Experimental
Arm Title
Penetrating Keratoplasty (KP)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)
Intervention Description
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.
The host cornea bed will be prepared with an excimer laser.
Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed.
Intervention Type
Procedure
Intervention Name(s)
Penetrating Keratoplasty (KP)
Intervention Description
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.
The donor cornea is then sutured where the patient's cornea was.
Primary Outcome Measure Information:
Title
Number of LALAK patients with post operative complications compared to PK patients
Description
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bibiana Reiser, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OCT-guided LALAK in Children
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