High Resolution Wavefront-guided vs. Wavefront Optimized... | NCT02565537

Studies
High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

NCT02565537

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 24, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Nearsightedness
Astigmatism

Interventions

LASIK

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Apr 1, 2025Actual

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Sep 29, 2015

First Posted Date

Oct 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2025

Last Update Posted Date

Apr 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edward E. Manche, Principal Investigator, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iDesign WFG LASIK	Active Comparator	Wavefront-guided LASIK	Procedure: LASIK
Wavelight WFO LASIK	Active Comparator	Wavefront-optimized LASIK	Procedure: LASIK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LASIK	Procedure	WFG vs. WFO LASIK	Wavelight WFO LASIK iDesign WFG LASIK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected visual acuity		Twelve months

Secondary Outcomes

Measure	Description	Time Frame
Quality of vision and quality of life using the QoV questionnaire		One month, three months, six months 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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward E. Manche, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Palo Alto	California	94303	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34788593	Background	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.

ID	Term
D009216	Myopia
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques