Wavefront-guided LASIK for Presbyopia

Recruiting at 8 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AMO Development, LLC

Must not be taking: Antimetabolites, Accutane, Cordarone, Corticosteroids

Disqualifiers: Pregnancy, Diabetes, Glaucoma, Autoimmune, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

383 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves eye surgery to help people with vision problems achieve stable eyesight. It targets individuals who need surgical correction for their vision. The surgery works by fixing how the eyes focus light, leading to clearer and more stable vision.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that may affect healing, such as antimetabolites, isotretinoin, and amiodarone hydrochloride, within specific time frames before treatment. Additionally, if you are using inhaled or systemic corticosteroids, you are not eligible to participate.

Is Wavefront-guided LASIK safe for treating presbyopia?

Research shows that Wavefront-guided LASIK for presbyopia is generally safe, with studies reporting good safety outcomes in patients aged 40 to 69. However, some patients may experience side effects like glare, halos, or reduced night vision, which can sometimes be corrected with additional procedures. ^{1 2 3 4 5}

How is Wavefront-guided LASIK treatment unique for presbyopia?

Wavefront-guided LASIK for presbyopia is unique because it uses a customized approach to minimize optical aberrations (imperfections in vision) and improve visual outcomes for near, intermediate, and distance vision. This method is designed to be more precise and predictable compared to traditional LASIK treatments, which were not commonly used for presbyopia due to induced visual distortions. ^{4 6 7 8 9}

Research Team

AMO Development, LLC Clinical Trial

Principal Investigator

AMO Development, LLC

Eligibility Criteria

This trial is for people over 40 with myopia and presbyopia who need at least +1.25 D to +2.00 D reading add power, have stable vision, and can follow the study's schedule. Pregnant women or those on certain medications affecting healing are excluded.

Inclusion Criteria

Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm

Your cornea has to be thick enough to safely perform the surgery, which means it needs to have a certain minimum thickness after taking into account the planned treatment depth.

A stable refractive error (based on a previous exam, medical records, lensometry, or prescription that is at least 12 months prior to the preoperative manifest refraction), as defined by a change of less than or equal to 0.50 D in MRSE (sphere and cylinder)

Exclusion Criteria

I cannot tolerate monovision correction as per a contact lens trial.

Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device

You have had a bad reaction or your body doesn't respond well to any of the medications used after surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits as per schedule for each operative eye

Treatment Details

Interventions

• Wavefront-guided LASIK

Trial Overview The trial tests a LASIK surgery using iDesign Refractive Studio with STAR S4 IR® Excimer laser System for monovision correction in myopic subjects with presbyopia over a period of 12 months across multiple centers.

Participant Groups

Group I: Wavefront-guided Lasik Monovision Treatment Experimental Treatment 1 Intervention

Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio.

Wavefront-guided LASIK is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Wavefront-guided LASIK for:

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Approved in Canada as Wavefront-guided LASIK for:

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Approved in European Union as Wavefront-guided LASIK for:

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Who Is Running the Clinical Trial?

AMO Development, LLC

Lead Sponsor

Trials

1

Recruited

380+

Findings from Research

LASIK surgery demonstrated good safety and efficacy in a presbyopic population aged 40 to 69, with 80% to 100% of eyes achieving 20/30 vision or better after the procedure.

While older patients showed a trend toward higher retreatment rates and slightly worse visual outcomes, there was no significant risk of visual loss, indicating that LASIK remains a viable option for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LASIK in the presbyopic age group: safety, efficacy, and predictability in 40- to 69-year-old patients. Ghanem, RC., de la Cruz, J., Tobaigy, FM., et al.[2022]

In a study of 277 patients undergoing simultaneous LASIK and Kamra corneal inlay implantation for hyperopic presbyopia, all age groups achieved a mean uncorrected distance visual acuity (UDVA) of 20/20, indicating the procedure is safe and effective across different ages.

Patients aged 60 to 65 (Group 3) experienced the greatest improvement in both UDVA and uncorrected near visual acuity (UNVA), along with the highest satisfaction levels, suggesting that age considerations can enhance postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year results of simultaneous laser in situ keratomileusis and small-aperture corneal inlay implantation for hyperopic presbyopia: comparison by age. Tomita, M., Waring, GO.[2015]

Six years after undergoing PresbyLASIK, patients showed excellent visual outcomes with a mean binocular uncorrected distance visual acuity of 20/18, indicating the procedure is both safe and effective for correcting presbyopia.

Postoperative assessments revealed stable corneal aberrations and improved near vision quality, with a notable 8% re-treatment rate, suggesting that while the procedure is effective, some patients may still require additional interventions for optimal satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes After LASIK Using a Hybrid Bi-aspheric Micro-monovision Ablation Profile for Presbyopia Correction. Luger, MHA., McAlinden, C., Buckhurst, PJ., et al.[2020]

A 72-year-old patient experienced improved near vision after undergoing Supracor LASIK for presbyopia and hyperopia, but faced significant side effects like glare and reduced distance vision due to treatment decentration.

The patient successfully underwent a reversal procedure using wavefront-guided treatment, which restored 20/25 distance vision and eliminated the dysphotopsia symptoms, marking a novel approach to correcting unsatisfactory outcomes from Supracor LASIK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of a presbyopic LASIK treatment. Ang, RE., Reyes, RM., Solis, ML.[2020]

LASIK surgery for presbyopia showed good near vision improvement and high predictability, with 94% of patients achieving a refractive outcome within ±1.00 diopter, based on a review of 28 studies involving 15,861 eyes.

However, there was a noted decrease in distance vision efficacy and safety after the procedure, indicating that while LASIK can effectively improve near vision, it may compromise distance vision quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, Predictability, and Stability of LASIK for Presbyopia Correction: A Systematic Review and Meta-analysis. Zhang, G., Cao, H., Qu, C.[2023]

A novel customization algorithm used in LASIK surgery for presbyopia treatment significantly reduced higher order optical aberrations, leading to improved visual outcomes.

After six months, 78% of the 36 presbyopic subjects achieved 20/20 vision or better for near vision, with 92% for intermediate and 86% for distance vision, indicating the procedure's safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Laser Refractive Surgical Treatment for Presbyopia: Optics-Based Customization for Improved Clinical Outcome. Pajic, B., Pajic-Eggspuehler, B., Mueller, J., et al.[2018]

PresbyLASIK, a new treatment strategy using excimer lasers to create a multifocal cornea, shows promise as a potential solution for presbyopia, which currently lacks effective surgical options.

While initial clinical results are encouraging, further controlled studies are necessary to address unresolved questions regarding the safety and efficacy of this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PresbyLASIK: treatment approaches with the excimer laser]. Becker, KA., Jaksche, A., Holz, FG.[2018]

A study of 92 patients showed that combining the PresbyMAX treatment in the nondominant eye with standard LASIK in the dominant eye effectively corrected both myopia and presbyopia, with all patients achieving 20/20 or better binocular vision at 6 months post-surgery.

The results indicate that this treatment is safe and effective, as 84% of dominant eyes achieved 20/16 vision, and all patients reached J2 or better for near vision, demonstrating significant improvements in both distance and near visual acuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presbyopia correction using the monocular bi-aspheric ablation profile in myopic eyes. Ryu, S., Jun, I., Kang, DSY., et al.[2023]

In a study of 28 patients aged around 56 years, the novel bilateral presbyopic LASIK technique achieved 100% of patients having 20/20 or better distance vision at 6 months, significantly outperforming the 57% success rate of traditional monovision treatment.

The new LASIK method also provided better intermediate and near vision outcomes compared to monovision, with high patient satisfaction reported, indicating its effectiveness in treating presbyopic hyperopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Laser-Induced Increased Depth of Field for the Simultaneous Correction of Hyperopia and Presbyopia. Rahmania, N., Salah, I., Rampat, R., et al.[2021]

References

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

LASIK in the presbyopic age group: safety, efficacy, and predictability in 40- to 69-year-old patients. [2022]

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

One-year results of simultaneous laser in situ keratomileusis and small-aperture corneal inlay implantation for hyperopic presbyopia: comparison by age. [2015]

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

Long-term Outcomes After LASIK Using a Hybrid Bi-aspheric Micro-monovision Ablation Profile for Presbyopia Correction. [2020]

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

Reversal of a presbyopic LASIK treatment. [2020]

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

Efficacy, Safety, Predictability, and Stability of LASIK for Presbyopia Correction: A Systematic Review and Meta-analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Laser Refractive Surgical Treatment for Presbyopia: Optics-Based Customization for Improved Clinical Outcome. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

[PresbyLASIK: treatment approaches with the excimer laser]. [2018]

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

Presbyopia correction using the monocular bi-aspheric ablation profile in myopic eyes. [2023]

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

Clinical Effectiveness of Laser-Induced Increased Depth of Field for the Simultaneous Correction of Hyperopia and Presbyopia. [2021]