LASIK for Near-sightedness and Astigmatism

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: 59th Medical Wing

Must not be taking: Isotretinoin, Antimetabolites

Disqualifiers: Keratoconus, Glaucoma, Autoimmune diseases, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two LASIK surgery methods to correct nearsightedness and astigmatism. Participants will undergo LASIK using Contoura with Phorcides on one eye and LASIK using iDesign on the other to determine which method is more effective. It suits individuals who have been nearsighted for some time and have mild to moderate astigmatism in both eyes. Participants should live within 60 miles of Lackland AFB and be Tricare Prime or Select beneficiaries. As an unphased trial, this study allows participants to contribute to advancing LASIK technology and potentially benefit from cutting-edge surgical techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Isotretinoin (Accutane) or antimetabolites.

What prior data suggests that these LASIK techniques are safe for correcting myopia?

Research has shown that LASIK using Contoura with Phorcides is generally well-tolerated. Many patients report high satisfaction with their vision after this treatment. Strong evidence indicates it improves vision, particularly for those seeking very sharp vision, such as 20/15 or better. Most people do not experience major side effects and are pleased with their vision post-procedure.

For LASIK using iDesign, studies have indicated it is safe and effective. It significantly reduces the risk of vision loss compared to older LASIK methods. The treatment has consistently produced positive results, improving vision and reducing the need for glasses or contact lenses over time.

Both treatments in the trial have a strong safety record. Most people tolerate them well and notice improvements in their vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these LASIK techniques for near-sightedness and astigmatism because they offer precision and personalization beyond current options. The LASIK using Contoura with Phorcides employs advanced topography-guided laser technology, which customizes the ablation process to an individual's unique corneal shape, potentially enhancing vision quality. On the other hand, LASIK using iDesign takes a wavefront-guided approach, using a detailed map of the eye's surface to correct vision errors with remarkable accuracy. Both methods aim to improve visual outcomes, reduce side effects, and provide a tailored experience, distinguishing them from conventional LASIK procedures.

What evidence suggests that this trial's treatments could be effective for correcting myopia?

This trial will compare two LASIK methods for correcting nearsightedness and astigmatism. Studies have shown that LASIK using Contoura with Phorcides is highly effective, with 98% of patients achieving 20/20 vision or better. It also corrects complex imperfections on the eye's surface that can affect vision. One study found that this method can improve vision to 20/15, which is even sharper than 20/20.

Similarly, LASIK using iDesign, another treatment option in this trial, has been highly successful. Research shows that 100% of patients achieve 20/40 vision or better six months after the procedure. The iDesign system uses advanced technology for precise vision correction. Both treatments offer excellent improvements in vision, making them strong options for correcting nearsightedness and astigmatism, a common condition that causes blurred vision. ^{1 2 3 5 6}

Who Is on the Research Team?

Samantha B Rodgers, MD

Principal Investigator

59th Medical Wing

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness and/or mixed astigmatism who are seeking LASIK surgery. Participants will have one eye treated with the Contoura Topolyzer using Phorcides calculations, and the other eye treated with iDesign calculations.

Inclusion Criteria

Have similar levels of astigmatism in each eye (0.75D of difference between eyes)

Total spherical equivalent (SE) of no more than -9.0 D

Tricare Prime or Tricare Select Beneficiary

Exclusion Criteria

Pregnant or nursing females

I have a condition like diabetes that could affect how my wounds heal.

I have abnormal findings in my cornea or conditions that affect its shape and health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo LASIK using Contoura with Phorcides on one eye and LASIK using iDesign on the contralateral eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual outcomes, quality of vision, and dry eye symptoms

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LASIK

Trial Overview The study compares two methods of LASIK surgery: Contoura Topolyzer guided by Phorcides analytics on one eye versus iDesign-guided LASIK on the other. The goal is to determine which method provides better vision correction for myopia and astigmatism.

How Is the Trial Designed?

Group I: LASIK using Contoura with Phorcides Active Control 1 Intervention

Alcon VISX Star S4 IR LASIK ablation calculation using Contoura with Phorcides

Group II: LASIK using iDesign Active Control 1 Intervention

Alcon VISX Star S4 IR LASIK ablation calculation using iDesign Refractive Studio 2.0

Who Is Running the Clinical Trial?

59th Medical Wing

Lead Sponsor

Trials

42

Recruited

12,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026343/

Clinical outcomes after topography-guided LASIK One topography-guided LASIK procedure (Contoura Vision, Alcon) has been shown to provide excellent visual outcomes in normal eyes without irregular astigmatism ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07128316

LASIK Using Contoura With Phorcides vs. iDesign The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., ...

3. crstoday.com crstoday.com/articles/patient-reported-outcomes-after-wavelight-topography-guided-contoura-vision-lasik-using-phorcides/patient-reported-outcomes-after-wavelight-topography-guided-contoura-vision-lasik-using-phorcides

Patient Reported Outcomes after Wavelight ® Topography- ... The Phorcides^ software has shown improved vision outcomes compared to manual treatment planning, particularly at the 20/15 and better level.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0279357

Comparison of refractive and visual acuity results after ... Comparison of refractive and visual acuity results after Contoura® Vision topography-guided LASIK planned with the Phorcides Analytic Engine to ...

5. raymondfongmd.com raymondfongmd.com/blog/lasik/why-contoura-lasik-is-better-than-smile/

Why is Contoura LASIK better than SMILE？ With a success rate of 98% for achieving 20/20 vision or better, coupled with the ability to address higher-order corneal aberrations, Contoura ...

6. withpower.com withpower.com/trial/phase-astigmatism-7-2022-81e94

Contoura with Phorcides and WaveLight Wavefront ... Research shows that Contoura with Phorcides is generally well-tolerated. Many patients report high satisfaction with their vision after this treatment.