High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

NCT ID: NCT02565537

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2025-04-01

Brief Summary

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.

Detailed Description

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.

Conditions

Nearsightedness; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iDesign WFG LASIK

Wavefront-guided LASIK

Group Type: ACTIVE_COMPARATOR

LASIK

Intervention Type: PROCEDURE

WFG vs. WFO LASIK

Wavelight WFO LASIK

Wavefront-optimized LASIK

Group Type: ACTIVE_COMPARATOR

LASIK

Intervention Type: PROCEDURE

WFG vs. WFO LASIK

Interventions

LASIK

WFG vs. WFO LASIK

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Edward E. Manche

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward E. Manche, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Countries

United States

References

Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.

Reference Type: BACKGROUND

PMID: 34788593 (View on PubMed)

Other Identifiers

34288

Identifier Type: -

Identifier Source: org_study_id