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NCT Number: NCT01673503

A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Carl Zeiss Meditech VisuMax laser

Device

Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser

Other names: Refractive lenticule extraction, ReLEx

Primary outcomes

  1. Visual acuity

    Time frame: up to 6 months

    Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart

Secondary outcomes

  1. refractive predictability

    Time frame: Pre-surgery, 1 week, 1 month, 3 months, 6 months

    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

Other outcomes

  1. Corneal biomechanics, corneal nerve changes and dry eye symptoms

    Time frame: pre-surgery and 6 months after

    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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2011
First posted
Aug 28, 2012
Registry last updated
Jan 24, 2013

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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