OCT-guided LALAK for KCN

NCT01901614 | Terminated Results

• 2 other identifiers: OHSU IRB00009280- PTKR01EY018184
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a new procedure, called laser-assisted lamellar anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of potential complications after surgery compared to another corneal transplant procedure. The current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire cornea. The LALAK procedure involves transplanting only the top layers of the cornea instead of the entire cornea. Only one eye will have this experimental procedure performed. If both eyes need to have surgery your doctor will help you decide on the best non-study option for your other eye.

Conditions

Corneal Opacity; Keratoconus

Keywords

Keratoconus; Corneal Opacity; Keratoplasty

Outcome Measures

Primary Outcomes (1)

• Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK.

  The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis.

  24 months

Study Arms (2)

LALAK

EXPERIMENTAL

laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.

Procedure: LALAK; Device: optical coherence tomography (OCT); Drug: Topical Anesthesia; Device: femtosecond laser

IEK

ACTIVE COMPARATOR

Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.

Procedure: IEK; Drug: Retrobulbar Block or General Anesthesia; Device: femtosecond laser

Interventions

LALAK PROCEDURE

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.

LALAK

IEK PROCEDURE

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.

IEK

Retrobulbar Block or General Anesthesia DRUG

IEK

optical coherence tomography (OCT) DEVICE

OCT will be used to guide the depth of the graft and donor dissections.

LALAK

Topical Anesthesia DRUG

LALAK

femtosecond laser DEVICE

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.

IEK; LALAK

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eyes with keratoconus 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).

You may not qualify if:

• Preoperative corneal thickness less than 400 microns.
• Corneal edema
• Central guttata
• Inability to give informed consent.
• Inability to maintain stable fixation for OCT imaging.
• Inability to commit to required visits to complete the study.
• Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
• Patients with severe collagen vascular diseases or ocular surface disorders

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Corneal Opacity; Keratoconus

Interventions

Anesthesia, General; Tomography, Optical Coherence; Anesthesia

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: David Huang, MD, PhD
• Organization: Oregon Health & Science University

huangd@ohsu.edu

503-494-3000

Study Officials

• Winston Chamberlain, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Winston Chamberlain, MD, PhD, Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 17, 2013
• Study Start: August 1, 2013
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

US (1)