Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

Stanford University

Status: Begins enrollment this month

Conditions: Myopia; Astigmatism

Treatments: Procedure: LASIK

Study type: Interventional

Funder types: Other

Identifiers

NCT07078799

81344

Details and patient eligibility

About

We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.

Full description

We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.

Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).

One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.

We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial.

The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment.

Participants scheduled to undergo LASIK for the correction of myopia (nearsightedness) will be screened for eligibility. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study.. If a participant elects to undergo a re-treatment of the initial LASIK surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis.

The primary aim of the research is to compare outcomes between the two procedures. All of the procedures performed during the study are considered standard of care for LASIK surgeries.

Enrollment: 70 estimated patients

Sex: All

Ages: 22 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 22 and older

2. People with healthy eyes:

   1. No abnormal corneal shape
   2. No excessively thin corneas
   3. No eye diseases such as glaucoma or cataracts

3. Nearsightedness between -1.00 diopters and -10.00 diopters.

4. Subjects with less than or equal to 3.00 diopters of astigmatism.

5. Subjects must have similar levels of nearsightedness in each eye.

Exclusion criteria

1. Subjects under the age of 22.
2. Subjects with excessively thin corneas.
3. Subjects with topographic evidence of keratoconus.
4. Subjects with ectactic eye disorders.
5. Subjects with autoimmune diseases.
6. Subjects who are pregnant or nursing at the time of surgery. (The FDA-approved labelling indications for LASIK specifically excludes patients who are pregnant or nursing. There is no strict prohibition not to become pregnant during the one year study period)
7. They can not be more than 1.5 diopter of difference between eyes.
8. Subjects with more than 3.00 diopters of astigmatism
9. Subjects with disimilar levels of astigmatism in each eye (They can not have more than 0.75 diopters of difference between eyes) -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Wavefront-guided laser ablation

Active Comparator group

Description:

Wavefront-guided LASIK

Treatment:

Procedure: LASIK

Procedure: LASIK

Ray tracing-guided LASIK

Active Comparator group

Description:

Ray-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye

Treatment:

Procedure: LASIK

Procedure: LASIK