A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Anders H. Vestergaard, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01673503
First received: August 20, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Myopia
Astigmatism
Device: Carl Zeiss Meditech VisuMax laser
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart


Secondary Outcome Measures:
  • refractive predictability [ Time Frame: Pre-surgery, 1 week, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Corneal biomechanics, corneal nerve changes and dry eye symptoms [ Time Frame: pre-surgery and 6 months after ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 35
Study Start Date: May 2011
Arms Assigned Interventions
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 Name: 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 Name: Refractive lenticule extraction, ReLEx

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673503

Locations
Denmark
Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
Aarhus, Denmark, 8000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Investigators
Principal Investigator: Anders H Vestergaard, MD Odense University Hospital, University of Southern Denmark
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders H. Vestergaard, MD, PhD student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01673503     History of Changes
Other Study ID Numbers: S-20100111
Study First Received: August 20, 2012
Last Updated: January 23, 2013
Health Authority: Denmark: University of Southern Denmark
Denmark: Department of Ophthalmology at both Odense University Hospital and Aarhus University Hospital - Aarhus Sygehus.
Denmark: The Regional Scientific Ethical Committee for Southern Denmark
Denmark: The Central Denmark Region Committees on Health Research Ethics
Denmark: The Danish Data Protection Agency

Keywords provided by Odense University Hospital:
Myopia
refractive surgery
all femtosecond laser
ReLEx flex
ReLEx smile

Additional relevant MeSH terms:
Myopia
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014