A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Odense University Hospital

Status and phase: Completed; Phase 3

Conditions: Myopia; Astigmatism

Treatments: Device: Carl Zeiss Meditech VisuMax laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01673503

S-20100111

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Carl Zeiss Meditech VisuMax laser - ReLEx flex

Active Comparator group

Description:

\>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

Treatment:

Device: Carl Zeiss Meditech VisuMax laser

Carl Zeiss Meditech VisuMax laser - ReLEx smile

Active Comparator group

Description:

\>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

Treatment:

Device: Carl Zeiss Meditech VisuMax laser