Trial document




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  DRKS00006141

Trial Description

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Title

Clinical Investigation of ReLEx hismile with the VisuMax femtosecond laser system

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Trial Acronym

---

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URL of the Trial

http://---

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Brief Summary in Lay Language

ReLEx smile is a treatment option for myopia correction in refractive laser surgery that has been CE marked since 2011 and more than 200,000 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 (VisuMax, Carl Zeiss Meditec) 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, comparable to aspheric profiles used in LASIK.

This prospective, non-comparative and non-randomized international multicenter study is the first use of the ReLEx hismile treatment option in people and is therefore designed as a feasibility study.

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Brief Summary in Scientific Language

The scientific description of the lenticule extraction method ReLEx smile can be found in the following publications:
1) Verdaguer P et al. Small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism. J Emmetropia 2013; 4: 191-196.
2) Ivarsen A, Hjortdal J. Correction of myopic astigmatism with small incision lenticule extraction. J Refract Surg. 2014 Apr;30(4):240-7.
3) Sekundo W1, Gertnere J, Bertelmann T, Solomatin I. One-year refractive results, contrast sensitivity, high-order aberrations and complications after myopic small-incision lenticule extraction (ReLEx SMILE). Graefes Arch Clin Exp Ophthalmol. 2014 May;252(5):837-43.

ReLEx hismile is simply a modified version of ReLEx smile such that the lens of tissue removed follows an aspheric profile, comparable to aspheric profiles used in LASIK for excimer surgery.

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Organizational Data

  •   DRKS00006141
  •   2014/06/27
  •   [---]*
  •   no
  •   Approved
  •   14/SS/0081, South East Scotland Research Ethics Committee 02 Edinburgh
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Secondary IDs

  •   CIV-14-03-011924 
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Health Condition or Problem studied

  •   H52 -  Disorders of refraction and accommodation
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Interventions/Observational Groups

  •   ReLEx hismile: Refractive correction of myopia and myopia with astigmatism with the VisuMax femtosecond laser system by an aspheric design of the corneal lenticule
  •   ReLEx smile: Historical data of a refractive correction of myopia and myopia with astigmatism with the VisuMax femtosecond laser system by a spheric design of the corneal lenticule
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The principal objective of the study is to investigate the aspheric profile using ReLEx hismile as a treatment option compared to the current ReLEx smile spherical profile.
The focus of the research is to measure the change in the so called spherical aberration as a measure of optical quality. Spherical aberration will be measured using both a corneal topographer and a wavefront aberrometer at each visit.

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Secondary Outcome

The secondary objective of the study will be an extensive analysis of the refractive and visual outcomes at each follow-up visit. This analysis will follow the routine analysis of data in refractive surgery research. The study will also include analysis of corneal surface data (topography) and whole eye optics (wavefront aberrometry). Objective and subjective visual quality will also be assessed by measuring contrast sensitivity and by using a patient questionnaire pre- and postoperative.

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Countries of Recruitment

  •   Latvia
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/03/02
  •   48
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

-Subjects should be 18 years of age or older
-Calculated residual stromal thickness (RST)>250 μm
-Normal corneal topography
- Contact lens wearers must stop wearing their rigid or soft contact lenses before baseline measurements according to local requirements of the clinic
-Distance refraction must be stable within the last twelve months
-only myopic patients or patients with myopia and astigmatism (sphere within -0.50D to -10.00D, cylinder up to 5.00D)
-The corrected distance visual acuity shall be 20/25 or better in each eye pre-operatively.
-Patients with a wavefront analysis diameter of at least 5mm (undilated) pre-OP
-Patient shall be able to understand the patient information and willing to sign an informed consent
-Patient shall be willing to comply with all follow-up visits


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Exclusion Criteria

• Previous intraocular or corneal surgery of any kind on the eye being treated.
• Intake of systemic medications which affect wound healing (e.g. corticosteroids)
• Treatment with medications such as steroids or immune-suppressants
• Diagnosis of an autoimmune disease, connective tissue disease or diabetes
• Unstable central keratometry readings with irregularities
• Herpes simplex or herpes zoster keratitis
• The patient is not able to lie flat in a horizontal position
• The patient cannot make him/herself understood and react to instructions
• The patient does not tolerate local or topical anaesthesia
• Pregnant or nursing women (or women, who planning pregnancy during the study)
• Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g.
– Cataract
– Suspected glaucoma or an intraocular pressure >21 mm of Hg
– Corneal disease
– Corneal thinning disorder, e.g. keratoconus,
– Pellucid marginal corneal degeneration
– Dystrophy of the basal membrane
– Corneal oedema
– Exudative macular degeneration
– Infection
Any residual, recurrent, or active abnormality of the cornea to be treated, e.g.
- Existing corneal implant
- Corneal lesion
- Unstable refraction
- Connective tissue disease
- Dry eye, Sicca

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Addresses

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    • Carl Zeiss Meditec AG
    • Göschwitzer Strasse 51-52
    • 07745  Jena
    • Germany
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    • Acu Centrs
    • Mr.  Prof.  Igors  Solomatins 
    • Elizabetes 75
    • 1050  Riga
    • Latvia
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    • MV Sante Vision
    • Mr.  Dr.  Christian  De Courten 
    • Avenue DE Rhodanie 70
    • 1007  Lausanne
    • Switzerland
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    • Carl Zeiss Meditec AG
    • Ms.  Regina  Schütt 
    • Göschwitzer Strasse 51-52
    • 07745  Jena
    • Germany
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    • London Vision Clinic Laser Eye Surgery
    • Mr.  Prof  Dan  Reinstein 
    • 138 Harley Street
    • W1G 7LA  London
    • United Kingdom
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Sources of Monetary or Material Support

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    • Carl Zeiss Meditec AG
    • Göschwitzer Strasse 51-52
    • 07745  Jena
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/19
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.