High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

Not Applicable

Active, not recruiting

• Conditions: Nearsightedness; Astigmatism
• Interventions: Procedure: LASIK

• Registration Number: NCT02565537
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Study Start: 2015-10
• Study First Posted: 2015-10-01
• Primary Completion: 2021-06-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-23
• Last Update Posted: 2024-06-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iDesign WFG LASIK	LASIK	Wavefront-guided LASIK
Wavelight WFO LASIK	LASIK	Wavefront-optimized LASIK

Primary Outcome Measures

Name	Time	Method
Uncorrected visual acuity	Twelve months

Secondary Outcome Measures

Name	Time	Method
Quality of vision and quality of life using the QoV questionnaire	One month, three months, six months and twelve months
Change in best spectacle corrected visual acuity	One, three, six and twelve months
Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success	One, three six and twelve months
Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)	One, three, six and twelve months
Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)	One day, one month, three months, six months and twelve months

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States