Clinical Investigation ReLEx hismile - version 1.2 dated 17/01/2014
Research type
Research Study
Full title
Clinical investigation of ReLEx hismile with the VisuMax femtosecond laser system
IRAS ID
151512
Contact name
Dan Reinstein
Contact email
Sponsor organisation
Carl Zeiss Meditec AG
Research summary
ReLEx smile is a treatment option for myopia correction in refractive laser surgery that has been CE marked since
2011 and more than 40,000 procedures have been performed worldwide. ReLEx smile is the same as LASIK in that a lens of tissue is removed from the cornea to reshape the cornea and focus
the vision. The difference is that the lens of tissue is delineated using a femtosecond laser which is then manually extracted in one piece through a small incision, rather than being removed using an excimer laser. Up to now, the shape of the lens of tissue removed with ReLEx smile has been like a sphere (spherical profile) – the same shape that was used when LASIK was first performed. LASIK is now routinely performed using what is called an aspheric profile, which is more similar to the natural curvature of the cornea such that it is steeper centrally and slightly flatter
further out. Using an aspheric profile has significantly improved the optical quality achieved by LASIK and has reduced
the risk and incidence of night vision disturbances and reduced contrast sensitivity. ReLEx hismile is simply a modified version of ReLEx smile such that the lens of tissue removed follows an aspheric profile, exactly the same as that used in LASIK.
This is a prospective, noncomparative and nonrandomized
international multicenter study is the first use of the ReLEx
hismile treatment option in people and is therefore designed as a feasibility study as the first part of the process of
obtaining general approval for the procedure (CE marking).
This trial is an international study that will be conducted in three sites, one in Latvia, one in Switzerland and one in
United Kingdom.A total of 48 eyes will be taking part with at least 12 treated eyes at each study site.
The preoperative visit, surgery and postoperative visits are defined to be the same as for patients treated with ReLEx smile in routine care.REC name
South East Scotland REC 02
REC reference
14/SS/0098
Date of REC Opinion
20 Jun 2014
REC opinion
Further Information Favourable Opinion