NCT02301598

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

8 months

First QC Date

November 20, 2014

Last Update Submit

November 26, 2014

Conditions

KeratoconusCorneal Opacity

Keywords

femtosecond laseranterior lamellar keratoplastyatomic-force microscopy

Outcome Measures

Primary Outcomes (4)

  • Mean endothelial cell loss

    12 months after surgery

  • Mean postoperative astigmatism

    12 months after surgery

  • UCVA (uncorrected visual acuity)

    12 months after surgery

  • BSCVA (best spectacle-corrected visual acuity)

    12 months after surgery

Secondary Outcomes (4)

  • Corneal hysteresis

    12 months after surgery

  • Corneal resistance factor

    12 months after surgery

  • Central corneal thickness

    12 months after surgery

  • Residual recipient's tissue thickness

    12 months after surgery

Study Arms (1)

FS-ALK

EXPERIMENTAL

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)

Interventions

FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)PROCEDURE

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

Also known as: Femto-ALK
FS-ALK

Eligibility Criteria

Age18 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KeratoconusCorneal Opacity

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Boris Malyugin, MD,PhD,prof.

    The S.N. Fedorof Federal State Institution

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alexey Pashtaev MD, PhD

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 26, 2014

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-11