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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small incision lenticule extraction | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Only patients who are medically suitable for corneal refractive surgery can be included in the study.
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.
Any residual, recurrent, or active abnormality of the cornea to be treated, e.g.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Z Reinstein, MD MA | London Vision Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Vision Clinic | London | W1G 7LA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23231737 | Background | 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. | |
| 25437479 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Tobramycin and dexamethasone: Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure Ofloxacin: Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure Proxymetacaine 0.5%: Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure Oxybuprocaine 0.4%: Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2016 |
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| Tobramycin and dexamethasone | Drug | Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure |
|
| Ofloxacin | Drug | 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 |
|
| 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 |
| 24112634 | Background | 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. |
| 25804585 | Background | 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. |
| 21183108 | Background | 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. |
| 25250415 | Background | 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. |
| 20601657 | Result | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Tobramycin and dexamethasone: Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure Ofloxacin: Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure Proxymetacaine 0.5%: Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure Oxybuprocaine 0.4%: Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 smaller standard deviation represents a more accurate and more predictable outcome. | Posted | Mean | Standard Deviation | Diopters | 1 year postop | eyes | eyes |
|
|
| |||||||||||||||||||||||||
| Secondary | 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. | Percentage of eyes where the postop uncorrected distance visual acuity (UDVA) was within 1 line of preop corrected distance visual acuity (CDVA) | Posted | Number | Percentage of eyes | 1 year postop | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Percentage of eyes with loss of 2 or more lines of corrected distance visual acuity (CDVA) | Posted | Number | Percentage of eyes | 1 year postop | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Percentage of eyes with spherical equivalent refraction within +/- 1.00 D of the intended target | Posted | Number | Percentage of eyes | 1 year postop | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Percentage of eyes with refractive cylinder up to 1.00 D after SMILE | Posted | Number | Percentage of eyes | 1 year postop | eyes | eyes |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Percentage of eyes with change in SEQ more than 0.50 D between 3 and 12 months | Posted | Number | Percentage of eyes | 3 months and 1 year postop | eyes | eyes |
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| Secondary | 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. | Change in total mean Rasch-scaled quality of vision score (including all symptoms) for bothersomeness | Posted | Mean | Standard Deviation | scores on the Rasch scale | 1 year postop | eyes | eyes |
| |||||||||||||||||||||||||||
| Secondary | 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. | Change in corneal spherical aberration between 3 and 12 months | Posted | Mean | Standard Deviation | Microns change spherical aberration | 1 year postop | eyes | eyes |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Tobramycin and dexamethasone: Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure Ofloxacin: Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure Proxymetacaine 0.5%: Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure Oxybuprocaine 0.4%: Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure | 0 | 114 | 0 | 114 | 10 | 114 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal ectasia | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| Subjective visual disturbance | Eye disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dan Z Reinstein | London Vision Clinic | 02072214005 | dzr@londonvisionclinic.com |
| Apr 19, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D003907 | Dexamethasone |
| D015242 | Ofloxacin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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