Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

The S.N. Fyodorov Eye Microsurgery State Institution

Status: Completed

Conditions: Corneal Opacity; Keratoconus

Treatments: Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)

Study type: Interventional

Funder types: Other

Identifiers

NCT02301598

FS-1

Details and patient eligibility

About

The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities

Full description

Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.

Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.

All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.

Enrollment: 13 patients

Sex

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced keratoconus or stromal corneal scattering
• Normal endothelial cell density

Exclusion criteria

• Acute keratoconus in the anamnesis
• Low endothelial cell density
• Age under 18 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

FS-ALK

Experimental group

Description:

Femtosecond laser-assisted maximum thickness anterior lamellar keratoplasty (FS-ALK) was performed for 11 eyes of 11 patients with advanced keratoconus and 2 eyes of 2 patients with superficial corneal scattering.

Treatment:

Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)