Laser Keratoplasty for Presbyopia

(Opti-K™ Trial)

Recruiting at 3 trial locations

Overseen By Joshua Cohen, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VIS, Inc.

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

Disqualifiers: Ocular surface disease, Cloudy cornea, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 1

Duration: Single treatment session

75 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 9 10 11}

Research Team

Harry Glen, M.D.

Principal Investigator

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.

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)

Treatment Details

Interventions

• Optimal laser keratoplasty

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

VIS, Inc.

Lead Sponsor

Trials

4

Recruited

610+

Total Diversity Clinical Trial Management

Collaborator

Trials

1

Recruited

80+

Findings from Research

In a study of 20 patients undergoing bilateral optimal keratoplasty, no serious complications were reported, indicating that the procedure is safe and well-tolerated.

Patients experienced significant improvements in both near and distance vision, with uncorrected near visual acuity improving notably within a day of treatment and maintained satisfaction throughout the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Keratoplasty for the Correction of Presbyopia and Hypermetropia. Veritti, D., Sarao, V., Lanzetta, P.[2020]

Conductive keratoplasty (CK) is a safe and effective treatment for presbyopia, showing significant improvements in near visual acuity for both post-LASIK and non-LASIK patients after 6 months and 1 year.

There were no significant differences in visual outcomes between post-LASIK and non-LASIK patients, indicating that CK can be reliably used in both groups without affecting the predictability of results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conductive keratoplasty for the treatment of presbyopia: comparative study between post- and non-LASIK eyes. Tomita, M., Watabe, M., Ito, M., et al.[2022]

In a study of 16 patients (32 eyes), both monocular and micro-monovision presbyLASIK effectively corrected presbyopia, with 90% of patients achieving 20/20 uncorrected distance vision after monocular treatment.

Monocular treatments provided better distance vision outcomes, while micro-monovision treatments offered improved intermediate vision, suggesting that patient preferences should guide the choice of treatment type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Two Treatment Modes of PresbyLASIK: Monocular vs. Micro-Monovision. Agarwal, S., Thornell, E.[2022]

Conductive keratoplasty (CK) significantly improves uncorrected visual acuity (UCVA) for both distance and near vision, with 82% of eyes achieving better near vision compared to control eyes in a study of 72 postoperative eyes.

CK introduces a small amount of surgically induced astigmatism (mean SIA of 0.23 diopters) and increases higher-order optical aberrations, which may enhance near vision function, as evidenced by 80% of patients achieving J3 or better binocular UCVA at near and high satisfaction rates in a clinical trial of 150 subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optics of conductive keratoplasty: implications for presbyopia management. Hersh, PS.[2019]

In a study of 46 hyperopic patients undergoing LASIK for presbyopia, the procedure significantly improved near vision, with uncorrected near acuity improving from J10 to J1 postoperatively (P<.0001).

The method, which involved using photopic pupillometry to guide the selection of optical zone diameters, resulted in high patient satisfaction (average score of 8.8 out of 10) and reduced spectacle dependence, with no patients needing full-time glasses after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photopic pupillometry-guided laser in situ keratomileusis for hyperopic presbyopia. Assil, KK., Chang, SH., Bhandarkar, SG., et al.[2022]

In a study of 941 corneal transplants over 10 years, adverse events were more frequent than previously reported, with intraoperative complications occurring in 12.4% of procedures and postoperative issues like graft rejection in 29.8%.

At 2 years post-surgery, 58.7% of patients achieved good visual acuity (≥6/12), and the graft survival rates were 87.9% for penetrating keratoplasty, indicating that while complications are common, many patients still benefit significantly from the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal Transplantation in New Zealand 2000 to 2009. Crawford, AZ., Krishnan, T., Ormonde, SE., et al.[2018]

Conductive keratoplasty (CK) demonstrated significant improvement in near vision for presbyopic patients, with 90% achieving near uncorrected visual acuity of J1 or better after 12 months, despite a slight decrease in distance vision.

The procedure was safe, with no loss of best spectacle-corrected visual acuity and no significant induced astigmatism, indicating that CK can be an effective option for treating presbyopia in patients aged 46 to 56.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conductive keratoplasty for presbyopia: 1-year results. Stahl, JE.[2022]

Conductive keratoplasty (CK) significantly improved near visual acuity in both hyperopic and emmetropic patients after 24 months, indicating its effectiveness for treating presbyopia.

The procedure was found to be safe and stable over the follow-up period, with no significant changes in contrast sensitivity, intraocular pressure, or other ocular health indicators, suggesting a low risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conductive keratoplasty for presbyopia and two years follow-up]. Xu, W., Wu, W., Yao, K., et al.[2011]

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]

In a study of 20 eyes from patients who previously underwent conductive keratoplasty for presbyopia, photorefractive keratectomy (PRK) using a 213 nm laser showed promising results, with 47% achieving good near vision (Jaeger 3 or better) and 27% achieving good distance vision (20/25 or better) after 6 months.

The procedure was safe, as no patients experienced a significant loss in corrected distance visual acuity or developed notable corneal haze, indicating that PRK can be an effective option for improving vision in presbyopic patients post-CK.

NCBI (Pubmed)

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. Felipe, AF., Agahan, AL., Cham, TL., et al.[2011]

A new procedure using excimer laser PRK with a specially designed mask successfully corrected presbyopia in three patients, achieving stable near vision improvement (+3.00 D) over a 24-month follow-up period.

The treatment did not negatively impact uncorrected distance vision and showed only a slight decrease in contrast sensitivity, indicating a promising safety profile for this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excimer laser photorefractive keratectomy for presbyopia: 24-month follow-up in three eyes. Vinciguerra, P., Nizzola, GM., Bailo, G., et al.[2022]

References

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

Optimal Keratoplasty for the Correction of Presbyopia and Hypermetropia. [2020]

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

Conductive keratoplasty for the treatment of presbyopia: comparative study between post- and non-LASIK eyes. [2022]

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

Early Outcomes of Two Treatment Modes of PresbyLASIK: Monocular vs. Micro-Monovision. [2022]

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

Optics of conductive keratoplasty: implications for presbyopia management. [2019]

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

Photopic pupillometry-guided laser in situ keratomileusis for hyperopic presbyopia. [2022]

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

Corneal Transplantation in New Zealand 2000 to 2009. [2018]

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

Conductive keratoplasty for presbyopia: 1-year results. [2022]

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

[Conductive keratoplasty for presbyopia and two years follow-up]. [2011]

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

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

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]

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

Excimer laser photorefractive keratectomy for presbyopia: 24-month follow-up in three eyes. [2022]