Wavefront-guided PRK vs Wavefront-optimized PRK

Myopia Clinical Trial

Official title:

A Prospective, Randomized Comparison of Fellow Eyes Undergoing Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091934
• Other study ID #: Stanford IRB #29233
• Status: Completed
• Phase: N/A
• Start date: April 1, 2009
• Est. completion date: March 31, 2012

Study information

• Verified date: November 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the results of PRKK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism

Description:

This is a research study comparing the outcomes of PRK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 50 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo refractive keratectomy (PRK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will not know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) PRK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo PRK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Patients will complete questionnaires preoperatively and postoperatively evaluating quality of vision and quality of life. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your PRK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.

Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 31, 2012
• Est. primary completion date: March 31, 2012
• 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 -8.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria:

• Subjects under the age of 21.

• Excessively thin corneas.

• Topographic evidence of keratoconus.

• Ectactic eye disorders.

• Autoimmune diseases.

• Pregnant or nursing.

• Patients must have similar levels of nearsightedness in each eye. They can not be more than 2.5 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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Procedure:
• Wavefront-guided PRK
Wavefront-guided PRK
• Wavefront-optimized PRK
Wavefront-optimized PRK

Locations

Country	Name	City	State
United States	Stanford Eye Laser Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876. Erratum in: JAMA Ophth — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected visual acuity	Uncorrected visual acuity	One year
Secondary	Topographic analysis	Topographic analysis	One year
Secondary	Wavefront analysis	Wavefront analysis	One year
Secondary	Quality of vision and quality of life questionnaire	Patient Reported Outcomes Questionnaire	One year
Secondary	Corneal haze	Corneal haze	One year
Secondary	Changes in best corrected 5 and 25% contrast visual acuity	Changes in best corrected 5 and 25% contrast visual acuity	One year
Secondary	Changes in best corrected visual acuity	Changes in best corrected visual acuity	One year
Secondary	Refractive predictability	Refractive predictability	One year