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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42181

Enrollment

Registered

2015-02-17

Start date

2016-04-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

keratoconus

Interventions

FS laser aided keratoplasty or MALK.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years. Informed consent. Severe KC needing keratoplasty.

Exclusion criteria

Exclusion criteria: Unable to attend the FU visits. Mental retardation, including trisomy 21. Severe progressive glaucoma. History of retinal surgery, glaucoma surgery or age related macular disease. Severe nystagmus. History of surgical correction of astigmatism. History of corneal or refractive surgery.

Design outcomes

Primary

Measure	Time frame
Astigmatism.	—

Secondary

Measure	Time frame
Visus (BSCVA, UCVA, BclCVA). Endothelial cell density. Number of eyes that need a hard contactlens to achieve a VA > 0.5 at 1 year. Graft survival. RMS of Zernike polynomials of high order aberrations. Contrast sensitivity and stray light. Quality of vision questionnaire. OT time and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

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