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A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

NCT ID: NCT03063164

Last Updated: 2021-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-14

Study Completion Date

2018-11-13

Brief Summary

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Comparing LASIK outcomes using two femtosecond lasers

Detailed Description

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Patients 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 patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Conditions

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Myopia Astigmatism

Keywords

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Femtosecond laser Visumax Intralase IFS150 LASIK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eye to eye comparison
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intralase IFS

Intralase IFS vs. Visumax

Group Type ACTIVE_COMPARATOR

Intralase IFS150

Intervention Type DEVICE

Intralase flap creation

Visumax

Visumax vs. Intralase iFS

Group Type ACTIVE_COMPARATOR

Visumax

Intervention Type DEVICE

Visumax flap creation

Interventions

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Intralase IFS150

Intralase flap creation

Intervention Type DEVICE

Visumax

Visumax flap creation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria

* Subjects under the age of 21
* Subjects over the age of 60
* Subjects with corneal ectatic disorders
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edward E. Manche

OTHER

Sponsor Role lead

Responsible Party

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Edward E. Manche

Professor of Ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Edward Manche, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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33356

Identifier Type: -

Identifier Source: org_study_id