A Randomized, Comparative Trial of Two Mushroom Keratoplasty Techniques in Keratoconus Patients. Femtosecond Laser Aided True Mushroom Keratoplasy versus Microkeratome Assisted Lamellar Keratoplasty (MALK).

Rationale: With severe keratoconus (KC), refractive abnormalities become non-correctable and, eventually, a corneal transplant is the only treatment option left to restore vision. Continuing technological developments suggest that VA outcome and rehabilitation rate can be further improved. Surgical outcome, i.e. postoperative astigmatism, of femtosecond (FS) laser assisted mushroom keratoplasty and microkeratome assisted lamellar keratoplasty (MALK) will be compared.

Objective: To demonstrate that FS laser aided keratoplasty for KC is superior to MALK.

Study design: Randomized, comparative.

Study population: KC patients indicated for keratoplasty.
Intervention: FS laser aided keratoplasty or MALK.

Main study parameters/endpoints: Astigmatism.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The outcome of FS laser aided mushroom keratoplasty is expected to be better but the risk of endothelial complications is supposed to be higher. Assessments for this study are non-invasive and inconvenience is negligible. Extra time required for these measurements is approximately 1 hour per visit (5X).

Femtosecond (FS) laser aided keratoplasty for KC is superior to MALK.

baseline, 1, 3, 6, 12 month

Femtosecond laser aided keratoplasty; MALK