A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia

The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Carl Zeiss Meditech VisuMax laser

• Study Type: Interventional
• Enrollment: 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 25 to 45 years,
• moderate to high myopia with astigmatism =< 2 D,
• otherwise eye healthy,
• CDVA of 0.8 or better (Snellen).

Exclusion Criteria:

• systemic or ocular disease or previous eye surgery,
• thin cornea,
• a difference of more than 2 D myopia in the eyes of each subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carl Zeiss Meditech VisuMax laser - ReLEx flex; >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile	Device: Carl Zeiss Meditech VisuMax laser; Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser; Other Names: Refractive lenticule extraction, ReLEx
Active Comparator: Carl Zeiss Meditech VisuMax laser - ReLEx smile; >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile	Device: Carl Zeiss Meditech VisuMax laser; Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser; Other Names: Refractive lenticule extraction, ReLEx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
refractive predictability	Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability	Pre-surgery, 1 week, 1 month, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal biomechanics, corneal nerve changes and dry eye symptoms	Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.	pre-surgery and 6 months after

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Anders H Vestergaard, MD, Odense University Hospital, University of Southern denmark

Publications and helpful links

General Publications

• Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.

Study record dates

Study Major Dates

• Study Start: May 1, 2011

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Myopia; refractive surgery; all femtosecond laser; ReLEx flex; ReLEx smile
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Myopia
• Other Study ID Numbers: S-20100111