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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02565537
Other study ID # 34288
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date December 2025

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
LASIK
WFG vs. WFO LASIK

Locations

Country Name City State
United States Stanford University School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Uncorrected visual acuity Twelve months
Secondary Quality of vision and quality of life using the QoV questionnaire One month, three months, six months and twelve months
Secondary Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS) One day, one month, three months, six months and twelve months
Secondary 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
Secondary Change in best spectacle corrected visual acuity One, three, six and twelve months
Secondary 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
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