What is the mechanism of action of this treatment?

The most common treatments for astigmatism, such as SMILE and LASIK with Contoura and Phorcides, work by reshaping the cornea to correct refractive errors. SMILE is a minimally invasive procedure that removes a small piece of corneal tissue through a tiny incision, reshaping the cornea. LASIK with Contoura and Phorcides involves creating a corneal flap and using a laser to reshape the underlying tissue based on detailed topographic maps. These advanced techniques offer improved visual outcomes, faster recovery, and reduced complications, making them highly beneficial for astigmatism patients.

What side effects are associated with this type of intervention?

Common side effects of treatments for astigmatism, such as SMILE and LASIK with Contoura and Phorcides, include dry eyes, glare, halos, and starbursts around lights, particularly at night. LASIK may also involve complications related to the corneal flap, such as flap dislocation or epithelial ingrowth. Infections and inflammation are rare but possible. Both procedures are generally successful and well-received by patients, though individual results can vary.

What prior FDA approvals exist?

The FDA has approved several treatments for astigmatism, including LASIK and SMILE. LASIK (Laser-Assisted In Situ Keratomileusis) is a well-established procedure that reshapes the cornea to correct refractive errors, including astigmatism. Contoura Vision, an advanced topography-guided LASIK, received FDA approval for its ability to provide personalized corneal reshaping, enhancing visual outcomes. SMILE (Small Incision Lenticule Extraction) is a minimally invasive procedure that was FDA-approved for the treatment of myopia and astigmatism, offering a flapless alternative to traditional LASIK. Both treatments aim to improve visual acuity by precisely reshaping the cornea.

What other types of research exist?

Promising novel alternatives to SMILE and LASIK with Contoura and Phorcides for astigmatism patients include: 1) Advanced Surface Ablation (ASA) with the 1,050-Hz excimer laser and SPT software, which has shown improvement in uncorrected visual acuity by reducing superficial stromal irregularities. 2) Topography-guided photorefractive keratectomy (TG-PRK), which offers precise corneal reshaping based on individual topographic maps. 3) Small Incision Lenticule Extraction (SMILE) enhancements, such as secondary SMILE procedures or combined techniques with excimer laser ablation for fine-tuning residual refractive errors.

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Procedure

SMILE vs. LASIK for Near-Sightedness

N/A

Waitlist Available

Led By Charisma B Evangelista, MD

Research Sponsored by 59th Medical Wing

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial involves two types of laser eye surgeries to correct nearsightedness. It aims to compare which method provides better vision improvement and fewer side effects. Both surgeries work by reshaping the eye to help focus light better. One of the techniques is a recently developed, flapless procedure with positive results.

Who is the study for?

This trial is for men and women aged 21-50 with nearsightedness between -2.00 and -8.00 diopters, astigmatism up to 3.00 diopters, similar vision issues in both eyes, Tricare Prime beneficiaries, living within 60 miles of Lackland AFB.

What is being tested?

The study compares SMILE surgery on one eye versus LASIK using Contoura with Phorcides on the other eye to correct myopia (nearsightedness) and astigmatism.

What are the potential side effects?

Potential side effects may include discomfort or pain in the eyes, visual disturbances like glare or halos, dry eyes, potential need for retreatment or glasses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op

Secondary study objectives

Change in high contrast visual acuity at 6-month Post-Op

Change in refractive error at 6-month Post-Op

Other study objectives

Change in higher order aberrations at 6-month Post-Op

Change in low contrast visual acuity at 6-month Post-Op

Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: LASIK using Contoura with PhorcidesActive Control1 Intervention

LASIK using Contoura with Phorcides in one eye.

Group II: SMILEActive Control1 Intervention

small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for astigmatism, such as SMILE and LASIK with Contoura and Phorcides, work by reshaping the cornea to correct refractive errors. SMILE is a minimally invasive procedure that removes a small piece of corneal tissue through a tiny incision, reshaping the cornea. LASIK with Contoura and Phorcides involves creating a corneal flap and using a laser to reshape the underlying tissue based on detailed topographic maps. These advanced techniques offer improved visual outcomes, faster recovery, and reduced complications, making them highly beneficial for astigmatism patients.