MyopiaNCT02528123
VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
A study testing Small incision lenticule extraction, Tobramycin and dexamethasone and Ofloxacin in people with Myopia and Refractive Errors, run by London Vision Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- Small incision lenticule extraction, Tobramycin and dexamethasone and Ofloxacin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to 7 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myopia, Refractive Errors
- Being tested
- Small incision lenticule extraction, Tobramycin and dexamethasone, Ofloxacin, Proxymetacaine 0.5%, Oxybuprocaine 0.4%
- Keywords
- Small incision lenticule extraction (SMILE), Femtosecond laser
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small incision lenticule extractionProcedure or surgery
Also called ReLEx smile, SMILE
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.
Tobramycin and dexamethasoneDrug
Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure
OfloxacinDrug
Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure
Proxymetacaine 0.5%Drug
Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure
Oxybuprocaine 0.4%Drug
Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Small incision lenticule extraction | Experimental | 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. Receives: Procedure: Small incision lenticule extraction; Drug: Tobramycin and dexamethasone; Drug: Ofloxacin; Drug: Proxymetacaine 0.5%; Drug: Oxybuprocaine 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year postop
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startApr 2016
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Vision Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Reinstein, London Vision Clinic
- Investigators
- Dan Z Reinstein, MD MA, Principal investigator, London Vision Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528123
- Sponsor's protocol ID
- LoVC-004
- Status last verified
- Apr 2024
- First submitted
- 7 Aug 2015
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 23231737Reinstein 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.
PubMed 25437479Kamiya 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.
PubMed 24112634Moshirfar 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.
PubMed 25804585Shah 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.
PubMed 21183108Ganesh 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.
PubMed 25250415Sekundo 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.
PubMed 20601657