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

Primary Purpose

Myopia, Refractive Errors

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Small incision lenticule extraction
Tobramycin and dexamethasone
Ofloxacin
Proxymetacaine 0.5%
Oxybuprocaine 0.4%
Sponsored by
London Vision Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Small incision lenticule extraction (SMILE), Femtosecond laser

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London Vision Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Small incision lenticule extraction

Arm Description

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.

Outcomes

Primary Outcome Measures

Variability of the refractive predicatibility (standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure)
Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure

Secondary Outcome Measures

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
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
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.
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.
Stability of the spherical equivalent refraction
Measure the postoperative refraction at 1 day, 1 month, 3 months, and 12 months after the SMILE procedure and calculate the mean and standard deviation of spherical equivalent refraction for each time point.
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
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

Full Information

First Posted
August 7, 2015
Last Updated
February 21, 2020
Sponsor
London Vision Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02528123
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London Vision Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors
Keywords
Small incision lenticule extraction (SMILE), Femtosecond laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
187 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small incision lenticule extraction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Small incision lenticule extraction
Other Intervention Name(s)
ReLEx smile, SMILE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tobramycin and dexamethasone
Intervention Description
Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Intervention Description
Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure
Intervention Type
Drug
Intervention Name(s)
Proxymetacaine 0.5%
Intervention Description
Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure
Intervention Type
Drug
Intervention Name(s)
Oxybuprocaine 0.4%
Intervention Description
Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure
Primary Outcome Measure Information:
Title
Variability of the refractive predicatibility (standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure)
Description
Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy of uncorrected distance visual acuity
Description
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
Time Frame
1 year
Title
Safety of corrected distance visual acuity (change in corrected distance visual acuity)
Description
Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure
Time Frame
1 year
Title
Predictability of refractive correction
Description
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.
Time Frame
1 year
Title
Predictability of refractive astigmatism correction
Description
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.
Time Frame
1 year
Title
Stability of the spherical equivalent refraction
Description
Measure the postoperative refraction at 1 day, 1 month, 3 months, and 12 months after the SMILE procedure and calculate the mean and standard deviation of spherical equivalent refraction for each time point.
Time Frame
1 day, 1 month, 3 months, and 1 year
Title
Change in night vision disturbances (questionnaire)
Description
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
Time Frame
1 year
Title
Change in corneal higher order aberrations
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Z Reinstein, MD MA
Organizational Affiliation
London Vision Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Vision Clinic
City
London
ZIP/Postal Code
W1G 7LA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23231737
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.
Results Reference
background
PubMed Identifier
25437479
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. Erratum In: J Refract Surg. 2015 Jan;31(1):60. J Refract Surg. 2015 Jan;31(1):60.
Results Reference
background
PubMed Identifier
24112634
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.
Results Reference
background
PubMed Identifier
25804585
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.
Results Reference
background
PubMed Identifier
21183108
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.
Results Reference
background
PubMed Identifier
25250415
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.
Results Reference
background
PubMed Identifier
20601657
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.
Results Reference
result

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

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