A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01673503

Enrollment

Registered

2012-08-28

Start date

2011-05-31

Completion date

Unknown

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Myopia

Keywords

Myopia, refractive surgery, all femtosecond laser, ReLEx flex, ReLEx smile

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.

Interventions

DEVICECarl Zeiss Meditech VisuMax laser

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
refractive predictability	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

Measure	Time frame	Description
Corneal biomechanics, corneal nerve changes and dry eye symptoms	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026