VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Procedure: Small incision lenticule extraction; Drug: Tobramycin and dexamethasone; Drug: Ofloxacin; Drug: Proxymetacaine 0.5%; Drug: Oxybuprocaine 0.4%

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W1G 7LA
    • London Vision Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Small incision lenticule extraction; Patients with high myopia will undergo a SMILE procedure to correct their refraction. Proxymetacaine 0.5% and Oxybuprocaine 0.4% will be used as anaesthetic during the procedure. Tobramycin and dexamethasone, and ofloxacin will be used four times a day for one week after the procedure.

Procedure: Small incision lenticule extraction; The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.; Other Names: SMILE; ReLEx smile; Drug: Tobramycin and dexamethasone; Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure; Drug: Ofloxacin; Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure; Drug: Proxymetacaine 0.5%; Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure; Drug: Oxybuprocaine 0.4%; Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of the Refractive Predicatibility	Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. An accurate outcome is where the postoperative spherical equivalent is equal to the intended target spherical equivalent. A mean difference less than zero implies the outcome was undercorrected, whereas a mean difference greater than zero implies the outcomes was overcorrected. A smaller standard deviation represents a more accurate and more predictable outcome.	1 year postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Uncorrected Distance Visual Acuity	Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia. Analysis performed on the data from the 1 year postoperative visit.	1 year postop
Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity)	Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit.	1 year postop
Predictability of Refractive Correction	Measure the postoperative refraction and calculate the deviation from the intended target in terms of spherical equivalent. Mean, standard deviation and range will be calculated. The data will also be analyzed as a scatter plot by plotting the attempted vs achieved spherical equivalent refraction. The data will also be graphically displayed as a histogram. Analysis performed on the data from the 1 year postoperative visit.	1 year postop
Predictability of Refractive Astigmatism Correction	Measure the postoperative refractive astigmatism and calculate the deviation from the intended target. Mean, standard deviation and range will be calculated. The data will also be analyzed as a scatter plot by plotting the target induced astigmatism vs the surgically induced astigmatism. The data will also be graphically displayed as a histogram. Analysis performed on the data from the 1 year postoperative visit.	1 year postop
Stability of the Spherical Equivalent Refraction	Measure the postoperative refraction at 3 months and 12 months after the SMILE procedure and calculate the mean and standard deviation of spherical equivalent refraction for each time point.	3 months and 1 year postop
Change in Night Vision Disturbances (Questionnaire)	Provide the patient with a questionnaire to subjectively grade their quality of vision at night to assess whether this has changed after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. A Rasch scale of 0-100 was used. A score of 0 indicates no quality of vision disturbances. A score of 100 indicates severe quality of vision disturbances. The outcome is calculated as the difference between the Rasch score before and after surgery, reported as the change in Rasch score units.	1 year postop
Change in Corneal Higher Order Aberrations	Measure the corneal aberrations before and after the SMILE procedure using the Atlas topographer to evaluate the change in corneal aberrations due to the surgery. Analysis performed on the data from the 1 year postoperative visit.	1 year postop

Collaborators and Investigators

• Sponsor: London Vision Clinic
• Investigators: Principal Investigator: Dan Z Reinstein, MD MA, London Vision Clinic

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Refract Surg. 2015 Jan;31(1):60. J Refract Surg. 2015 Jan;31(1):60.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimated): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Femtosecond laser; Small incision lenticule extraction (SMILE)
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Anesthetics, Local; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Dexamethasone; Proxymetacaine; Ofloxacin; Tobramycin; Benoxinate
• Other Study ID Numbers: LoVC-004