Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

November 26, 2014 updated by: Alexey Pashtaev, The S.N. Fyodorov Eye Microsurgery State Institution
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 52 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FS-ALK
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.
Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Other Names:
  • Femto-ALK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean endothelial cell loss
Time Frame: 12 months after surgery
12 months after surgery
Mean postoperative astigmatism
Time Frame: 12 months after surgery
12 months after surgery
UCVA (uncorrected visual acuity)
Time Frame: 12 months after surgery
12 months after surgery
BSCVA (best spectacle-corrected visual acuity)
Time Frame: 12 months after surgery
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal hysteresis
Time Frame: 12 months after surgery
Evaluation of biomechanical qualities of the cornea
12 months after surgery
Corneal resistance factor
Time Frame: 12 months after surgery
Evaluation of biomechanical qualities of the cornea
12 months after surgery
Central corneal thickness
Time Frame: 12 months after surgery
measured by OCT (optical coherence tomography - Optovue)
12 months after surgery
Residual recipient's tissue thickness
Time Frame: 12 months after surgery
measured by OCT (optical coherence tomography - Optovue)
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Investigators

  • Study Director: Boris Malyugin, MD,PhD,prof., The S.N. Fedorof Federal State Institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 22, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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