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

Trial Summary

What is the purpose of this trial?

This trial compares two laser eye surgery techniques in patients looking to improve their vision. Both methods use lasers to reshape the cornea, enhancing visual clarity and patient satisfaction. One of the methods used in this trial has been shown to provide excellent visual 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.

How does the Contoura with Phorcides and WaveLight Wavefront Optimized treatment differ from other treatments for near-sightedness and astigmatism?

Contoura with Phorcides and WaveLight Wavefront Optimized treatment is unique because it uses advanced laser technology to precisely reshape the cornea, addressing both near-sightedness and astigmatism by optimizing the eye's surface for better vision. This approach is more personalized compared to traditional methods, potentially offering improved visual outcomes by considering the unique shape and irregularities of each patient's eye. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Contoura with Phorcides
• WaveLight Wavefront Optimized

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Non-Orthogonal Refractive Lenses for Non-Orthogonal Astigmatic Eyes. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Improving near vision in presbyopic eyes by selective treatment of high-order aberrations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Optimal astigmatism to enhance depth of focus after cataract surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Nonpupil adaptive optics for visual simulation of a customized contact lens. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of total higher-order aberrations on accommodation in pseudophakic eyes. [2014]