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Completed

NCT Number: NCT02301598

Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

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

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Key information

Conditions

Keratoconus Corneal Diseases Corneal Opacity Eye Diseases

Age range

18 year–52 year

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)

Procedure

The procedure was a non-penetrating transplantation of 80% thickness corneal graft

Other names: Femto-ALK

Primary outcomes

  1. Mean endothelial cell loss

    Time frame: 12 months after surgery

  2. Mean postoperative astigmatism

    Time frame: 12 months after surgery

  3. UCVA (uncorrected visual acuity)

    Time frame: 12 months after surgery

  4. BSCVA (best spectacle-corrected visual acuity)

    Time frame: 12 months after surgery

Secondary outcomes

  1. Corneal hysteresis

    Time frame: 12 months after surgery

    Evaluation of biomechanical qualities of the cornea

  2. Corneal resistance factor

    Time frame: 12 months after surgery

    Evaluation of biomechanical qualities of the cornea

  3. Central corneal thickness

    Time frame: 12 months after surgery

    measured by OCT (optical coherence tomography - Optovue)

  4. Residual recipient's tissue thickness

    Time frame: 12 months after surgery

    measured by OCT (optical coherence tomography - Optovue)

Sponsors and collaborators

Lead sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 26, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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