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LALAK for Opacities

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ClinicalTrials.gov Identifier: NCT01901601
Recruitment Status : Withdrawn (Modifying procedure.)
First Posted : July 17, 2013
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

July 2, 2013
July 17, 2013
April 6, 2018
July 2013
August 31, 2017   (Final data collection date for primary outcome measure)
  • BSCVA (Snellen chart) [ Time Frame: 24 months ]
    A primary outcome measures will be BSCVA (Snellen chart)
  • intraoperative perforation rate [ Time Frame: 24 months ]
    A primary outcome measure will be intraoperative perforation rate.
Same as current
Complete list of historical versions of study NCT01901601 on ClinicalTrials.gov Archive Site
  • postoperative refractive error [ Time Frame: 24 months ]
    A secondary outcome measures will be postoperative refractive error
  • topographic astigmatism [ Time Frame: 24 months ]
    A secondary outcome measures will be topographic astigmatism
  • interface clarity [ Time Frame: 24 months ]
    A secondary outcome measures will be interface clarity (masked OCT and confocal microscopy grading)
  • endothelial cell count [ Time Frame: 24 months ]
    A secondary outcome measures will be endothelial cell count (specular microscopy)
  • complications [ Time Frame: 24 months ]
    A secondary outcome measures will be complications (rejection, interface opacification, others).
Same as current
Not Provided
Not Provided
 
LALAK for Opacities
Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities

The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal transplantation, Intralase-enabled keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and does not have the risks associated with conventional IEK. Additionally, optical coherence tomography (OCT) will be used to guide the depth of the graft and donor dissections.

The data will be analyzed to understand whether the new technique (LALAK) can repeatedly achieve good visual outcomes with lower risk from the operation compared to the visual outcomes and risk associated with the current standard of care, IEK.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
STROMAL OPACITIES
  • Procedure: LALAK
    1. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
    2. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
  • Procedure: IEK
    1. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.
    2. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
  • Drug: Retrobulbar Block or General Anesthesia
  • Device: optical coherence tomography (OCT)
    OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness.
  • Drug: Topical Anesthesia
  • Device: femtosecond laser
    The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
  • Experimental: LALAK
    laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
    Interventions:
    • Procedure: LALAK
    • Drug: Retrobulbar Block or General Anesthesia
    • Device: optical coherence tomography (OCT)
    • Drug: Topical Anesthesia
    • Device: femtosecond laser
  • Active Comparator: IEK
    Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
    Interventions:
    • Procedure: IEK
    • Drug: Retrobulbar Block or General Anesthesia
    • Device: femtosecond laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
40
August 31, 2017
August 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eyes with corneal opacities that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density > 1,500/mm2).

Exclusion Criteria:

  1. Preoperative corneal thickness less than 400 microns.
  2. Inability to give informed consent.
  3. Corneal edema
  4. Central guttata
  5. Inability to maintain stable fixation for OCT imaging.
  6. Inability to commit to required visits to complete the study.
  7. Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
  8. Patients with severe collagen vascular diseases or ocular surface disorders
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01901601
OHSU IRB#00009282
R01EY018184 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
David Huang, Oregon Health and Science University
Oregon Health and Science University
  • National Institutes of Health (NIH)
  • National Eye Institute (NEI)
Principal Investigator: Winston Chamberlain, MD, PhD Casey Eye Institute, Oregon Health & Science University
Oregon Health and Science University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP