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Clinical Trials/NCT01673503
NCT01673503
Completed
Phase 3

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

Odense University Hospital1 site in 1 country35 target enrollmentMay 2011
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ConditionsMyopiaAstigmatism

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Myopia
Sponsor
Odense University Hospital
Enrollment
35
Locations
1
Primary Endpoint
Visual acuity
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anders H. Vestergaard

MD, PhD student

University of Southern Denmark

Eligibility 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.

Outcomes

Primary Outcomes

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

  • refractive predictability(Pre-surgery, 1 week, 1 month, 3 months, 6 months)

Study Sites (1)

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