Contoura with Phorcides and WaveLight Wavefront Optimized for Near-sightedness and Astigmatism

Recruiting at 3 trial locations

Overseen By Elise Meide, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Terveen

Disqualifiers: Severe dry eye, Glaucoma, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for planning LASIK eye surgery to treat near-sightedness and astigmatism. Researchers aim to determine which method provides better vision results and higher patient satisfaction after surgery. The procedure involves using either Contoura with Phorcides or WaveLight Wavefront Optimized. Suitable candidates have been preparing for LASIK, have stable vision, and possess a specific level of astigmatism. Participants should be in good overall and eye health and meet other specific criteria. As an unphased trial, this study allows participants to contribute to advancements in LASIK technology and potentially experience improved vision outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that soft contact lenses should be discontinued 3 days before the pre-op exam and procedure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Contoura with Phorcides is generally well-tolerated. Many patients report high satisfaction with their vision after this treatment. Specifically, many eyes treated with Contoura achieved clear vision, with astigmatism (blurred vision) measuring 0.25 D or less after three months, indicating good vision.

However, limited information exists on possible side effects, such as dry eyes, following this treatment. While it appears to improve vision, detailed safety data remains limited.

WaveLight Wavefront Optimized is a common technique in LASIK surgeries. Its widespread use and general safety suggest it is well-tolerated.

In summary, both treatments appear safe and well-tolerated, but discussing any concerns with a doctor before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Contoura with Phorcides and WaveLight Wavefront Optimized because these techniques offer new ways to plan LASIK procedures for treating near-sightedness and astigmatism. Unlike traditional LASIK methods, which typically rely on standard measurements of the eye, Contoura with Phorcides uses advanced topographic mapping to create a highly personalized treatment plan. This method aims to improve visual outcomes and reduce complications by tailoring the surgery to the unique curvature of each patient's cornea. Meanwhile, WaveLight Wavefront Optimized seeks to enhance the precision of LASIK by minimizing higher-order aberrations that can affect vision quality. These innovations represent a significant leap forward in customizing eye surgery for optimal results.

What evidence suggests that this trial's treatments could be effective for near-sightedness and astigmatism?

Research has shown that Contoura with Phorcides, a treatment option in this trial, can enhance vision, often helping individuals achieve 20/15 vision or better. Patients typically report higher satisfaction and fewer dry eye symptoms after surgery with this method compared to others. Studies also indicate that the Phorcides software used in planning LASIK surgeries enhances vision clarity. Conversely, WaveLight Wavefront Optimized, another treatment option in this trial, is a popular choice for LASIK, known for improving overall vision quality. Both treatments have demonstrated positive results, but Contoura with Phorcides might offer a slight advantage in patient satisfaction and specific vision improvements. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to comprehend informed consent and complete 1 month post-op visit

Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)

Exclusion Criteria

Patients under 21 years of age

Patients that have a BCDVA of 20/25 or worse in either eye

You have had eye surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo LASIK surgery using either Contoura with Phorcides or WaveLight Wavefront Optimized techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual acuity and quality of life post-surgery

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Contoura with Phorcides
• WaveLight Wavefront Optimized

How Is the Trial Designed?

Group I: Study: Phorcides Experimental Treatment 1 Intervention

Contoura with Phorcides used for surgical planning of LASIK procedure

Group II: Control: Wavefront Optimized Active Control 1 Intervention

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Who Is Running the Clinical Trial?

Daniel Terveen

Lead Sponsor

Trials

1

Recruited

120+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40963955/

Patient Reported Visual Outcomes, Dry Eye Symptoms ... The results of this study suggest improved patient reported satisfaction, reduced dry eye symptoms, and overall decrease in visual ...

2. 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.

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05848817

Patient Reported Satisfaction With Contoura LASIK ... The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11164091/

Retrospective Study Comparing Topography-Guided and ... The purpose of this study was to compare visual outcomes in patients that had LASIK with the Contoura Phorcides treatment plan to patients that had LASIK with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10418009/

Comparative analysis of outcomes following topography ... Seventy-three percent of eyes in the Contoura group versus 77% of eyes in the Phorcides group had a manifest cylinder of 0.25 D or less at 3 months, with 10% of ...

7. dovepress.com dovepress.com/article/download/106896

Patient Reported Visual Outcomes, Dry Eye Symptoms, ... 10 To date, there is minimal data on the subjective outcomes of patients that had laser refractive surgery with the Contoura Phorcides treatment ...