Clinical trial NCT02528123: VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
Official title: VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Errors
Keywords: Small incision lenticule extraction (SMILE)
Femtosecond laser
Lead sponsor: London Vision Clinic
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate the safety and effectiveness of treating myopia (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with the VisuMax femtosecond laser.

Detailed description: Laser refractive surgery (LASIK and PRK) has been established for 25 years to treat myopia (short-sightedness). Over this time, the technology has been significantly improved to enable safe treatment of myopia up to -15D. Improvements including changing the shape of the lens of corneal tissue removed to better match the natural shape, and increasing the diameter of the applied correction to cover larger pupil sizes, have greatly reduced side-effects such as night vision glare and halos. Similarly, safety has been improved by using a laser (femtosecond laser) to create the corneal flap rather than a blade (known as a microkeratome), meaning that the cornea is reliably left with more than the safe amount of tissue.

In 2006, a new method of laser refractive surgery was introduced, small incision lenticule extraction (SMILE), which provides a minimally invasive keyhole method as it avoids the need to create a flap. In SMILE, a single laser (femtosecond laser) is used to make two curved cuts inside the cornea (without breaching the outside) that separate the lens of tissue that needs removing to focus the vision. This lens of tissue is removed in once piece (rather than evaporated as in LASIK) through a small 2mm wide tunnel to the surface.

SMILE has been used to treat short-sightedness up to -10D for more than 200,000 procedures worldwide and has been shown to achieve similar results to LASIK. However, because no flap is needed, this upper part of the cornea can also contribute strength, meaning that the cornea is stronger after SMILE than after LASIK. It is also expected that the accuracy for higher corrections using SMILE would be better than LASIK because the potential inaccuracies associated with excimer lasers (used in LASIK) are eliminated. This study will investigate the results of SMILE for myopia above -10D.

Eligibility criteria: Inclusion Criteria:

Only patients who are medically suitable for corneal refractive surgery can be included in the study.

* Subjects should be 21 years of age or older
* Eyes with high myopia spherical equivalent between -9.00 D up to -14.00 D, with cylinder up to 7.00 D
* The corrected distance visual acuity will be 20/40 or better in each eye pre-operatively
* Calculated sub-lenticule thickness (SLT) ≥220 µm
* Calculated total uncut stromal thickness (TUST) ≥300 µm
* Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
* Patient will be able to understand the patient information and willing to sign an informed consent
* Patient will be willing to comply with all follow-up visits and the respective examinations as specified in the flow-chart

Exclusion Criteria:

* Previous intraocular or corneal surgery of any kind on the eye being treated
* Patient not being able to lie flat in a horizontal position
* Patient not being able to tolerate local or topical anesthesia
* Autoimmune diseases
* Sicca syndrome, dry eye
* Herpes viral (herpes simplex) infections
* Herpes zoster
* Diabetes
* Pregnant or nursing women (or who are planning pregnancy during the study)
* Patients with a weight of \> 135 kg
* 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

Primary outcomes:
measure: Variability of the Refractive Predicatibility
timeFrame: 1 year postop
Secondary outcomes:
measure: Efficacy of Uncorrected Distance Visual Acuity
timeFrame: 1 year postop
measure: Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity)
timeFrame: 1 year postop
measure: Predictability of Refractive Correction
timeFrame: 1 year postop
measure: Predictability of Refractive Astigmatism Correction
timeFrame: 1 year postop
measure: Stability of the Spherical Equivalent Refraction
timeFrame: 3 months and 1 year postop
measure: Change in Night Vision Disturbances (Questionnaire)
timeFrame: 1 year postop
measure: Change in Corneal Higher Order Aberrations
timeFrame: 1 year postop
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Vision Clinic
Study officials:
affiliation: London Vision Clinic
name: Dan Z Reinstein, MD MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjortdal JO, Vestergaard AH, Ivarsen A, Ragunathan S, Asp S. Predictors for the outcome of small-incision lenticule extraction for Myopia. J Refract Surg. 2012 Dec;28(12):865-71. doi: 10.3928/1081597X-20121115-01.
citation: Reinstein DZ, Carp GI, Archer TJ, Gobbe M. Outcomes of small incision lenticule extraction (SMILE) in low myopia. J Refract Surg. 2014 Dec;30(12):812-8. doi: 10.3928/1081597X-20141113-07.
citation: Kamiya K, Shimizu K, Igarashi A, Kobashi H. Visual and refractive outcomes of femtosecond lenticule extraction and small-incision lenticule extraction for myopia. Am J Ophthalmol. 2014 Jan;157(1):128-134.e2. doi: 10.1016/j.ajo.2013.08.011. Epub 2013 Oct 7.
citation: Moshirfar M, McCaughey MV, Reinstein DZ, Shah R, Santiago-Caban L, Fenzl CR. Small-incision lenticule extraction. J Cataract Refract Surg. 2015 Mar;41(3):652-65. doi: 10.1016/j.jcrs.2015.02.006.
citation: Shah R, Shah S, Sengupta S. Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery. J Cataract Refract Surg. 2011 Jan;37(1):127-37. doi: 10.1016/j.jcrs.2010.07.033.
citation: Ganesh S, Gupta R. Comparison of visual and refractive outcomes following femtosecond laser- assisted lasik with smile in patients with myopia or myopic astigmatism. J Refract Surg. 2014 Sep;30(9):590-6. doi: 10.3928/1081597X-20140814-02.
citation: Sekundo W, Kunert KS, Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.