LALAK for Opacities

Oregon Health & Science University (OHSU)

Status: Withdrawn

Conditions: STROMAL OPACITIES

Treatments: Device: optical coherence tomography (OCT); Procedure: LALAK; Drug: Retrobulbar Block or General Anesthesia; Procedure: IEK; Drug: Topical Anesthesia; Device: femtosecond laser

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01901601

R01EY018184 (U.S. NIH Grant/Contract)

OHSU IRB#00009282

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

LALAK

Experimental group

Description:

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

Treatment:

Device: femtosecond laser

Drug: Retrobulbar Block or General Anesthesia

Drug: Topical Anesthesia

Device: optical coherence tomography (OCT)

Procedure: LALAK

IEK

Active Comparator group

Description:

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

Treatment:

Device: femtosecond laser

Drug: Retrobulbar Block or General Anesthesia

Procedure: IEK