A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03067077
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 48.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Procedure: SMILE; Procedure: LASIK	N/A

Detailed Description

Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
• Actual Study Start Date: Mar 12, 2017
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SMILE SMILE surgery	Procedure: SMILE; SMILE surgery; Procedure: LASIK; LASIK surgery
Active Comparator: Wavefront-guided LASIK Wavefront-guided LASIK	Procedure: SMILE; SMILE surgery; Procedure: LASIK; LASIK surgery

Outcome Measures

Primary Outcome Measures

1. Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better [One year]

   ETDRS testing lane

Secondary Outcome Measures

1. Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity [One year]

   ETDRS testing lane

2. Aberrometry Measurements [One year]

   Increase in total higher order RMS (root mean squared) by greater than 0.5 microns

3. Patient Satisfaction [One year]

   Percentage of patients satisfied with surgery. Patients were asked yes or no.

4. Change in Corneal Sensation [One year]

   A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry

5. Dry Eye Symptoms as Measured by OSDI Index [One year]

   Worsening of ocular surface disease index (OSDI) score of greater than 25. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.

6. Analysis of Astigmatism [One year]

   Participant eyes with an increase in astigmatism of greater than 1.0 diopter

7. Anterior Segment Ocular Coherence Topography Analysis [One year]

   Humphrey Visante AS OCT

8. Predictability [One year]

   Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction

9. Stability [One year]

   Change in refractive error greater than one diopter over 1 to 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.

• Subjects with up to 3.00 diopters of astigmatism.

Exclusion Criteria:

• Subjects under the age of 22.

• Subjects with excessively thin corneas.

• Subjects with topographic evidence of keratoconus.

• Subjects with ectatic eye disorders.

• Subjects with autoimmune diseases.

• Subjects who are pregnant or nursing.

• Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.

• Subjects with 3.25 or more diopters of astigmatism

• Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute at Stanford	Palo Alto	California	United States	94303

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Edward E Manche, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol - Oct 6, 2020

More Information

Publications

None provided.

• Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT03067077
• Other Study ID Numbers: 39587
• First Posted: Mar 1, 2017
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Edward E. Manche, Professor of Ophthalmology, Stanford University: SMILE; LASIK; Myopia; Wavefront-guided
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Enrolled participants were to receive SMILE surgery in one eye and LASIK surgery in their fellow eye

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Period Title: Overall Study
STARTED	44	44
Received Surgery	40	39
COMPLETED	37	37
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants receive SMILE surgery in one eye and Wavefront-guided LASIK in the fellow eye.
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	21 47.7%
Male	23 52.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	19 43.2%
Caucasian	18 40.9%
Hispanic	2 4.5%
Indian	4 9.1%
Pacific Islander	1 2.3%
Region of Enrollment (Count of Participants)
United States	44 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
Description	ETDRS testing lane
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed 12 month follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Number [percentage of participant eyes]	94	83

2. Secondary Outcome

Title	Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
Description	ETDRS testing lane
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed the 12 month follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Count of Units [Eyes]	0	0

3. Secondary Outcome

Title	Aberrometry Measurements
Description	Increase in total higher order RMS (root mean squared) by greater than 0.5 microns
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Count of Units [Eyes]	0	0

4. Secondary Outcome

Title	Patient Satisfaction
Description	Percentage of patients satisfied with surgery. Patients were asked yes or no.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Count of Participants [Participants]	36 81.8%	36 NaN

5. Secondary Outcome

Title	Change in Corneal Sensation
Description	A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Count of Units [Eyes]	0	0

6. Secondary Outcome

Title	Dry Eye Symptoms as Measured by OSDI Index
Description	Worsening of ocular surface disease index (OSDI) score of greater than 25. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Patients who completed 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Count of Participants [Participants]	0 0%	0 NaN

7. Secondary Outcome

Title	Analysis of Astigmatism
Description	Participant eyes with an increase in astigmatism of greater than 1.0 diopter
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants with 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Count of Units [Eyes]	0	0

8. Secondary Outcome

Title	Anterior Segment Ocular Coherence Topography Analysis
Description	Humphrey Visante AS OCT
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The outcome could not be analyzed because the data were corrupted

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	0	0

9. Secondary Outcome

Title	Predictability
Description	Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed 12 months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
+/- 0.50 diopters	30	34
+/- 1.0 diopters	36	37

10. Secondary Outcome

Title	Stability
Description	Change in refractive error greater than one diopter over 1 to 12 months
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Participants who completed twelve months follow-up

Arm/Group Title	SMILE	Wavefront-guided LASIK
Arm/Group Description	SMILE surgery	Wavefront-guided LASIK
Measure Participants	37	37
Measure Eyes	37	37
Count of Units [Eyes]	0	0

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	Adverse events are reported per participant
Arm/Group Title	SMILE		Wavefront-guided LASIK
Arm/Group Description	SMILE surgery		Wavefront-guided LASIK
All Cause Mortality
	SMILE		Wavefront-guided LASIK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	SMILE		Wavefront-guided LASIK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	SMILE		Wavefront-guided LASIK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/44 (0%)
Eye disorders
Unable to remove SMILE lenticule	1/44 (2.3%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.