Trial Outcomes & Findings for VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia (NCT NCT02528123)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

1 year postop

Results posted on

2024-04-23

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	114 187
Overall Study COMPLETED	113 185
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Small Incision Lenticule Extraction n=114 Participants 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
Age, Categorical <=18 years	0 Participants n=114 Participants
Age, Categorical Between 18 and 65 years	114 Participants n=114 Participants
Age, Categorical >=65 years	0 Participants n=114 Participants
Age, Continuous	35 years STANDARD_DEVIATION 9 • n=114 Participants
Sex: Female, Male Female	67 Participants n=114 Participants
Sex: Female, Male Male	47 Participants n=114 Participants
Region of Enrollment United Kingdom	114 Participants n=114 Participants

PRIMARY outcome

Timeframe: 1 year postop

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Variability of the Refractive Predicatibility	-0.22 Diopters Standard Deviation 0.48

SECONDARY outcome

Timeframe: 1 year postop

Population: Percentage of eyes where the postop uncorrected distance visual acuity (UDVA) was within 1 line of preop corrected distance visual acuity (CDVA)

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Efficacy of Uncorrected Distance Visual Acuity	87 Percentage of eyes

SECONDARY outcome

Timeframe: 1 year postop

Population: Percentage of eyes with loss of 2 or more lines of corrected distance visual acuity (CDVA)

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity)	0 Percentage of eyes

SECONDARY outcome

Timeframe: 1 year postop

Population: Percentage of eyes with spherical equivalent refraction within +/- 1.00 D of the intended target

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Predictability of Refractive Correction	96 Percentage of eyes

SECONDARY outcome

Timeframe: 1 year postop

Population: Percentage of eyes with refractive cylinder up to 1.00 D after SMILE

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Predictability of Refractive Astigmatism Correction	93 Percentage of eyes

SECONDARY outcome

Timeframe: 3 months and 1 year postop

Population: Percentage of eyes with change in SEQ more than 0.50 D between 3 and 12 months

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Stability of the Spherical Equivalent Refraction	8 Percentage of eyes

SECONDARY outcome

Timeframe: 1 year postop

Population: Change in total mean Rasch-scaled quality of vision score (including all symptoms) for bothersomeness

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Change in Night Vision Disturbances (Questionnaire)	11 scores on the Rasch scale Standard Deviation 23

SECONDARY outcome

Timeframe: 1 year postop

Population: Change in corneal spherical aberration between 3 and 12 months

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.

Outcome measures

Outcome measures
Measure	Small Incision Lenticule Extraction n=185 eyes 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
Change in Corneal Higher Order Aberrations	0.41 Microns change spherical aberration Standard Deviation 0.16

Adverse Events

Small Incision Lenticule Extraction

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Small Incision Lenticule Extraction n=114 participants at risk 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
Eye disorders Corneal ectasia	0.88% 1/114 • Number of events 1 • 1 year
Eye disorders Subjective visual disturbance	7.9% 9/114 • Number of events 9 • 1 year

Additional Information

Prof Dan Z Reinstein

London Vision Clinic

Phone: 02072214005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place