Laser Keratoplasty for Presbyopia

(Opti-K™ Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: VIS, Inc.

Must not be taking: Corticosteroids, Antimetabolites, Amiodarone, others

Disqualifiers: Ocular surface disease, Cloudy cornea, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using systemic medications that may affect the study outcome, such as corticosteroids, antimetabolites, or certain other drugs. It's best to discuss your specific medications with the trial team.

What data supports the idea that Laser Keratoplasty for Presbyopia is an effective treatment?

The available research shows that Laser Keratoplasty for Presbyopia is effective because it significantly improves both near and distance vision. In a study with 20 patients, all participants experienced better near vision without glasses, and their distance vision improved from 20/38 to 20/22 the day after treatment. This improvement was maintained for six months. Additionally, patients reported higher satisfaction with their vision for both near and distance activities. The treatment is also described as safe, noninvasive, and pain-free.

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What safety data is available for laser keratoplasty for presbyopia?

The study titled 'Optimal Keratoplasty for the Correction of Presbyopia and Hypermetropia' provides safety data for this treatment. It involved 40 eyes of 20 patients undergoing bilateral optimal keratoplasty. The study reported no serious intra- or postoperative complications over a 6-month follow-up period. The procedure was described as safe, noninvasive, rapid, pain-free, and office-based, with significant improvements in visual acuity and patient satisfaction.

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Is the treatment Optimal laser keratoplasty a promising treatment for presbyopia?

Yes, Optimal laser keratoplasty is a promising treatment for presbyopia. It is safe, quick, and pain-free, improving both near and distance vision without the need for glasses. Patients reported high satisfaction with their vision after the treatment.

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Eligibility Criteria

This trial is for people with presbyopia, which is difficulty in reading or seeing at close range as they age. Participants should be slightly nearsighted, have normal vision (emmetropic), or be slightly farsighted. The treatment will focus on the non-dominant eye to improve near vision temporarily.

Inclusion Criteria

I am 40 years old or older.

Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR < 0.70) in the non-dominant eye

I will avoid any eye surgery during the study's follow-up.

Exclusion Criteria

I have a condition that makes my cornea cloudy.

I understand the research procedures and what is expected of me.

I have had eye surgery before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VIS Opti-K™ treatment in the non-dominant eye to improve near vision

Single treatment session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of uncorrected near visual acuity and subjective improvement

3 months

Multiple visits (in-person)

Participant Groups

The VIS Opti-K System is being tested for its ability to correct presbyopia by treating the non-dominant eye. This Phase III trial measures how well subjects can see up close without glasses after treatment and checks their satisfaction through a questionnaire.

Group I: Single arm treatment with the VIS Optimal Keratoplasty (Opti-K™) System Experimental Treatment 1 Intervention

Subjects who accept monovision will receive Opti-K™ treatment in the non-dominant eye. The fellow eye will not receive Opti-K™ treatment in this Pivotal Study. Eligible subjects will undergo a single retreatment

Optimal laser keratoplasty is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Opti-K for:

• Presbyopia
• Hyperopia

🇺🇸 Approved in United States as Opti-K for:

• Investigational device exemption (IDE) granted, not yet approved for sale or use

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Cornea & Laser Eye Institute Teaneck, NJ

Cohen Laser & Vision Center Boca Raton, FL

OCLI Vision - Oceanside Oceanside, NY

Claris Vision Eye Health South Dartmouth, MA

Who Is Running the Clinical Trial?

VIS, Inc. Lead Sponsor

Total Diversity Clinical Trial Management Collaborator

References

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

Optimal Keratoplasty for the Correction of Presbyopia and Hypermetropia. [2020] Purpose. To evaluate prospectively the safety and efficacy of optimal keratoplasty for the correction of hyperopia and presbyopia. Methods. Consecutive patients undergoing bilateral optimal keratoplasty for refractive presbyopic and hypermetropic corrections were enrolled. Each patient received a complete ophthalmologic examination at baseline, 1 hour, 1 day, 1 week, 1 month, 3 months, and 6 months after treatment. Results. The study included 40 consecutive eyes of 20 patients. All patients reached the 6-month follow-up. No serious intra- or postoperative complications were recorded. Monocular and binocular uncorrected near visual acuities improved significantly during the follow-up (p &lt; 0.001). Binocular uncorrected distance visual acuity in presbyopic patients improved from 0.28 logMAR to a maximum of 0.04 logMAR (from 20/38 to 20/22 Snellen equivalent) the day after the treatment and remained significantly better than baseline until the end of the follow-up. A significant improvement of patient satisfaction for near (p &lt; 0.001) and distance (p = 0.007) activities was seen the day after treatment and was maintained throughout the follow-up. Conclusions. Optimal keratoplasty is a safe, noninvasive, rapid, pain-free, office-based procedure. It offers low to moderate hyperopes and presbyopes an improvement in uncorrected near visual acuity while maintaining or improving their distance visual acuity.

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

Conductive keratoplasty for the treatment of presbyopia: comparative study between post- and non-LASIK eyes. [2022] To evaluate the efficacy and safety of conductive keratoplasty (CK) for the treatment of presbyopia and analyze the differences in the effects between post- and non-laser in situ keratomileusis (LASIK) eyes. Clinical preoperative factors that could affect the predictability of CK were also analyzed.

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

Early Outcomes of Two Treatment Modes of PresbyLASIK: Monocular vs. Micro-Monovision. [2022] To report the visual, refractive and subjective outcomes of presbyLASIK for the correction of presbyopia.

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

Optics of conductive keratoplasty: implications for presbyopia management. [2019] To define the corneal optics of conductive keratoplasty (CK) and assess the clinical implications for hyperopia and presbyopia management.

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

Photopic pupillometry-guided laser in situ keratomileusis for hyperopic presbyopia. [2022] To evaluate a method of surgically treating presbyopia in hyperopic patients having laser in situ keratomileusis (LASIK) by selecting excimer ablation optical zone diameters based on the photopic pupil.

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

Corneal Transplantation in New Zealand 2000 to 2009. [2018] To quantify all minor/major adverse events in a large cohort of consecutive corneal transplants, particularly in respect to penetrating keratoplasty (PKP).

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

Conductive keratoplasty for presbyopia: 1-year results. [2022] To assess the safety, efficacy, and stability of conductive keratoplasty (CK) in the treatment of presbyopia.

8. China pubmed.ncbi.nlm.nih.gov

[Conductive keratoplasty for presbyopia and two years follow-up]. [2011] To investigate the effect of conductive keratoplasty (CK) for presbyopia and 2 years follow-up.

9. Germany pubmed.ncbi.nlm.nih.gov

[PresbyLASIK: treatment approaches with the excimer laser]. [2018] Presbyopia represents the most common refractive error. There is currently no surgical treatment for presbyopia, which is effective, reliable, and safe. Excimer laser surgery has become a routine procedure for the correction of myopia, hyperopia, and astigmatism for years. Various treatment strategies for presbyopia have been brought forward using the excimer lasers. Besides monovision, creation of a multifocal cornea represents an attractive option. This procedure is also called "PresbyLASIK." Different ablation profiles to form a multifocal cornea are reviewed here and first clinical results are summarized."PresbyLASIK" is a new, interesting treatment strategy, with a huge potential for the future. At the present it should be used in controlled studies only because of some unsolved questions.

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

Photorefractive keratectomy using a 213 nm wavelength solid-state laser in eyes with previous conductive keratoplasty to treat presbyopia: Early results. [2011] To evaluate the efficacy and safety of photorefractive keratectomy (PRK) using a 213 nm wavelength solid-state laser to treat regression in eyes that had previous conductive keratoplasty (CK) for presbyopia.

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

Excimer laser photorefractive keratectomy for presbyopia: 24-month follow-up in three eyes. [2022] For some patients, standard optical correction for presbyopia is not satisfactory. Using a specially designed mask, we developed a procedure for correcting presbyopia with excimer laser photorefractive keratectomy (PRK).