A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

NCT03063164 | Completed Results FDA Device

• 1 other identifier: 33356
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing LASIK outcomes using two femtosecond lasers

Conditions

Myopia; Astigmatism

Keywords

Femtosecond laser; Visumax; Intralase IFS150; LASIK

Outcome Measures

Primary Outcomes (1)

• ETDRS Uncorrected Visual Acuity

  Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

  At post-operative month 12

Secondary Outcomes (6)

• Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness

  At postoperative month one

• Cochet Bonnet Asthesiometry Measurement of Corneal Sensation

  At postoperative month twelve

• Best Spectacle Corrected Visual Acuity

  Postoperative month 12

• Aberrometry

  One three, six and twelve months

• Questionnaire Measuring Patient Preference for Laser Device

  Intraoperative (Approximately 1 minute after completion of surgery)

Study Arms (2)

Intralase IFS

ACTIVE COMPARATOR

Intralase IFS vs. Visumax

Device: Intralase IFS150

Visumax

ACTIVE COMPARATOR

Visumax vs. Intralase iFS

Device: Visumax

Interventions

Intralase IFS150 DEVICE

Intralase flap creation

Intralase IFS

Visumax DEVICE

Visumax flap creation

Visumax

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects under the age of 21
• Subjects over the age of 60
• Subjects with corneal ectatic disorders

Sponsors & Collaborators

• Edward E. Manche: lead

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

The study did not meet its planned enrollment number

Results Point of Contact

• Title: Edward E. Manche
• Organization: Stanford University School of Medicine

edward.manche@stanford.edu

6507255765

Study Officials

• Edward Manche, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Eye to eye comparison

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 24, 2017
• Study Start: February 14, 2017
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)