A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Odense University Hospital35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia Astigmatism

Interventions

Carl Zeiss Meditech VisuMax laserDEVICE

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark

Aarhus, Denmark

Outcomes

Primary Outcomes

Visual acuity

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

Time frame: up to 6 months

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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