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OpenTrials
Completed

NCT Number: NCT02565537

High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.

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Key information

Conditions

Nearsightedness Astigmatism Eye Diseases Myopia Refractive Errors

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94303, United States

About this study

The 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 investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the CustomVue and which eye is treated with Wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients with excessively thin corneas.
  • Patients with topographic evidence of keratoconus.
  • Patients with ectatic eye disorders.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
  • Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes.

Treatment and study plan

LASIK

Procedure

WFG vs. WFO LASIK

Primary outcomes

  1. Uncorrected visual acuity

    Time frame: Twelve months

Secondary outcomes

  1. Quality of vision and quality of life using the QoV questionnaire

    Time frame: One month, three months, six months and twelve months

  2. Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)

    Time frame: One day, one month, three months, six months and twelve months

  3. Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)

    Time frame: One, three, six and twelve months

  4. Change in best spectacle corrected visual acuity

    Time frame: One, three, six and twelve months

  5. Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success

    Time frame: One, three six and twelve months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK

Important dates

Study start
2015
Primary completion
2021
Study completion
2025
First posted
Oct 1, 2015
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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