LALAK for Opacities

Not Applicable

Withdrawn

• Conditions: STROMAL OPACITIES
• Interventions: Procedure: LALAK; Procedure: IEK; Drug: Retrobulbar Block or General Anesthesia; Device: optical coherence tomography (OCT); Drug: Topical Anesthesia; Device: femtosecond laser

• Registration Number: NCT01901601
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LALAK	LALAK	laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
LALAK	Retrobulbar Block or General Anesthesia	laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
LALAK	optical coherence tomography (OCT)	laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
LALAK	Topical Anesthesia	laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
LALAK	femtosecond laser	laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
IEK	IEK	Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
IEK	Retrobulbar Block or General Anesthesia	Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
IEK	femtosecond laser	Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.

Primary Outcome Measures

Name	Time	Method
BSCVA (Snellen chart)	24 months	A primary outcome measures will be BSCVA (Snellen chart)
intraoperative perforation rate	24 months	A primary outcome measure will be intraoperative perforation rate.

Secondary Outcome Measures

Name	Time	Method
postoperative refractive error	24 months	A secondary outcome measures will be postoperative refractive error
topographic astigmatism	24 months	A secondary outcome measures will be topographic astigmatism
interface clarity	24 months	A secondary outcome measures will be interface clarity (masked OCT and confocal microscopy grading)
endothelial cell count	24 months	A secondary outcome measures will be endothelial cell count (specular microscopy)
complications	24 months	A secondary outcome measures will be complications (rejection, interface opacification, others).