A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Phase 3

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: Carl Zeiss Meditech VisuMax laser

• Registration Number: NCT01673503
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 25 to 45 years,
• moderate to high myopia with astigmatism =< 2 D,
• otherwise eye healthy,
• CDVA of 0.8 or better (Snellen).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carl Zeiss Meditech VisuMax laser - ReLEx flex	Carl Zeiss Meditech VisuMax laser	\>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
Carl Zeiss Meditech VisuMax laser - ReLEx smile	Carl Zeiss Meditech VisuMax laser	\>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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark; 🇩🇰 Aarhus, Denmark