ReLEx SMILE Hyperopia
Research type
Research Study
Full title
Use of the VisuMax™ femtosecond laser lenticule removal procedure for the correction of hyperopia with or without astigmatism
IRAS ID
225776
Contact name
Timothy Archer
Contact email
Sponsor organisation
Carl Zeiss Meditec AG
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Summary of Research
This clinical study is designed as a prospective, non-randomized international multicentre study to investigate the treatment of hyperopia with or without astigmatism by small incision lenticule extraction (SMILE) with the VisuMax femtosecond laser system.The study involves 8 centres internationally and will include a total of 374 eyes (of at least 187 patients). Each study clinic will treat at least 20 eyes, but no more than 94 eyes (25% of the total study population). Patients will be followed for 1 year including visits at 1 day, 1 week, 1, 3, 6, 9 and 12 months.
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in corneal refractive surgery.. The following devices and software options will be used during the clinical investigation:
Device: - VisuMax femtosecond laser for therapeutic and refractive applications of corneal surgery. The VisuMax and SMILE already have CE approval for the treatment of myopia.
Software: - ReLEx SMILE (Refractive Lenticule Extraction / Small Incision Lenticule Extraction).The focus of this investigation is on the indication for use, the procedure for the reduction or elimination of hyperopia (farsightedness) with or without astigmatism. ReLEx SMILE (software-license) has no CE approval for this indication.
The VisuMax laser is the only vision-correcting laser in the world to perform ReLEx SMILE surgery. The laser is able to sculpt surfaces of a lens-shaped section of tissue within the cornea, then create a small incision to surgically remove this section from within the cornea, without creating a LASIK flap.
The proposed treatment for hyperopia is the same as ReLEx SMILE for myopia (nearsightedness), except that the lenticule profile is designed to steepen rather than flatten the cornea. ReLEx SMILE for myopia is an approved and well-established treatment with extensive supporting published evidence for efficacy and safety, also demonstrating equivalent outcomes achieved by LASIK. Hyperopic correction by LASIK is also a well-established treatment.
Summary of Results
Endpoints on safety and effectiveness (respectively performance) were derived based on the recommendations of the applicable ANSI standard and the targets outlined in an FDA guidance. However, confidence intervals were used to define the fulfilment criterion of an endpoint rather than the mean or median values in percentage. This is a much stronger assessment of the results than usually done in previous evaluations of the FDA and ANSI criteria. The evaluation of the performance and safety of the investigational device demonstrated good safety and efficacy.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0859
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion