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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-12

Study Completion Date

2021-03-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SMILE

SMILE surgery

Group Type ACTIVE_COMPARATOR

SMILE

Intervention Type PROCEDURE

SMILE surgery

LASIK

Intervention Type PROCEDURE

LASIK surgery

Wavefront-guided LASIK

Group Type ACTIVE_COMPARATOR

SMILE

Intervention Type PROCEDURE

SMILE surgery

LASIK

Intervention Type PROCEDURE

LASIK surgery

Interventions

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SMILE

SMILE surgery

Intervention Type PROCEDURE

LASIK

LASIK surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes