ELITA System for Refractive Errors

Recruiting at 1 trial location

Overseen By Dari Parizadeh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Surgical Vision, Inc.

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

Disqualifiers: Diabetes, Autoimmune diseases, Glaucoma, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

450 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be a 2-phase, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system.

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

The trial does not specify if you need to stop all current medications. However, you cannot participate if you are using systemic medications that may impair healing, like antimetabolites, isotretinoin, or amiodarone, within certain time frames before treatment. Also, inhaled or systemic corticosteroids used in the past 6 months will exclude you from eligibility.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications that may impair healing, such as antimetabolites, isotretinoin (Accutane®) within 6 months, and amiodarone hydrochloride (Cordarone®) within 12 months. Additionally, the use of inhaled or systemic corticosteroids within the past 6 months is not allowed.

What data supports the idea that ELITA System for Refractive Errors is an effective treatment?

The available research does not provide specific data on the ELITA System for Refractive Errors. Instead, it focuses on phakic refractive lenses and intraocular lenses for correcting vision problems like myopia and hyperopia. These studies show that such lenses can be effective in improving vision over the long term, with some research indicating positive results even after ten years. However, without direct data on the ELITA System, we can't make a direct comparison or conclusion about its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of the ELITA System treatment for refractive errors?

The research on phakic refractive lenses (PRL) and phakic intraocular lenses (PIOL) shows that these treatments are effective in correcting high myopia (nearsightedness) and hyperopia (farsightedness) over long periods, suggesting that similar laser systems like the ELITA System could also be effective for refractive errors. ^{1 2 3 4 5}

What safety data is available for the ELITA System for Refractive Errors?

The provided research does not directly mention the ELITA System or ELITA Femtosecond Laser System. However, it discusses the safety and outcomes of phakic intraocular lenses (pIOLs) for correcting myopia and hyperopia. These studies highlight the predictability, stability, and efficacy of pIOLs, while also noting that long-term safety remains a concern. The research emphasizes the need for standardization and quality control to improve safety and prevent complications in pIOL implantation. This information may be relevant if the ELITA System is related to or uses similar technology. ^{6 7 8 9 10}

Is the ELITA System a promising treatment for vision problems?

Yes, the ELITA System, which uses femtosecond laser technology, is a promising treatment for vision problems. Femtosecond lasers are known for their precision and ability to make accurate cuts in eye surgeries, which can improve vision correction procedures like LASIK. This technology is also being explored for other eye conditions, showing its potential in the field of eye care. ^{11 12 13 14 15}

How is the ELITA System treatment different from other treatments for refractive errors?

The ELITA System, a femtosecond laser treatment, is unique because it uses ultrashort laser pulses to make precise cuts in the eye's corneal tissue, allowing for highly accurate and reproducible results in correcting refractive errors. This technology can cut in all directions with micrometric accuracy, which is not possible with traditional methods. ^{11 12 13 14 15}

Research Team

Johnson & Johnson Surgical Vision, Inc. Clinical Trials

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Eligibility Criteria

Adults over 22 with myopia up to -10.00 D and astigmatism up to -5.00 D, stable vision for at least a year, and good overall eye health can join this trial. They must not have used certain contact lenses recently and should be willing to follow the study's check-up schedule. Pregnant women or those on specific medications affecting healing are excluded.

Inclusion Criteria

My eye's cornea will remain thick enough after surgery.

BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA)

I haven't worn contact lenses for the required time before my eye measurements.

Exclusion Criteria

I have had eye surgery or have ongoing eye conditions.

I am not using medications that could affect healing, like Accutane or Cordarone.

My eyes are not eligible for specific laser treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Each subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye

1 week

1 visit (in-person) for follow-up

Pivotal Phase

Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors

6 months

Multiple visits (in-person) for monitoring and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Treatment Details

Interventions

• ELITA System

Trial Overview The ELITA System is being tested in adults with certain types of vision errors (myopia and astigmatism). The study will look at how safe and effective it is through two phases without comparing it to other treatments.

Participant Groups

Group I: ELITA System Experimental Treatment 1 Intervention

Each subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye (Feasibility Phase). Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will be considered only after the first eye 1-week follow up visit has been completed and safety criteria are met.

ELITA System is already approved in European Union, United States for the following indications:

Approved in European Union as ELITA Femtosecond Laser System for:

• Myopia with or without astigmatism up to -12 diopters of sphere, up to -6 diopters of cylinder, with the sum of sphere and cylinder between -1.00 and -12.00 diopters using minus cylinder convention
• LASIK flap creation

Approved in United States as ELITA Femtosecond Laser System for:

• Myopia with or without astigmatism up to -12 diopters of sphere, up to -6 diopters of cylinder, with the sum of sphere and cylinder between -1.00 and -12.00 diopters using minus cylinder convention
• LASIK flap creation

Who Is Running the Clinical Trial?

Johnson & Johnson Surgical Vision, Inc.

Lead Sponsor

Trials

40

Recruited

8,800+

Findings from Research

In a study of 143 myopic eyes over an average follow-up of 3.8 years, phakic refractive lens (PRL) implantation significantly reduced myopia from an average of -14.08 diopters to -0.45 diopters, demonstrating its efficacy in treating high myopia.

The procedure was found to be safe, with no cataract formation observed in any eyes up to 6 years post-operation, although some complications like temporary intraocular pressure increase and anterior capsule damage were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of phakic refractive lens implantation in eyes with high myopia. Portaliou, DM., Kymionis, GD., Panagopoulou, SI., et al.[2011]

Phakic refractive lens (PRL) implantation is a safe and effective procedure for correcting high hyperopia, with 93.75% of eyes achieving a refraction within +/-0.50 D of emmetropia after one year.

While the procedure showed high accuracy, about 31.25% of eyes experienced a mild loss in best spectacle-corrected visual acuity (BSCVA), indicating that some patients may need additional correction, such as LASIK, for residual astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 diopters: 1-year follow-up. Gil-Cazorla, R., Teus, MA., Arranz-Marquez, E., et al.[2019]

The implantation of phakic refractive lenses (PRL) in 31 eyes with high myopia and hyperopia showed promising results, with 82% of myopic eyes and 79% of hyperopic eyes achieving a postoperative spherical equivalent within +/-1.00 diopter of the desired refraction after one year.

The procedure was generally safe, with no significant complications like progressive cataracts or pigmentary glaucoma observed, although some patients experienced minor issues such as night halos and lens decentration requiring replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic refractive lens experience in Spain. Hoyos, JE., Dementiev, DD., Cigales, M., et al.[2019]

The Artisan phakic intraocular lens (PIOL) demonstrated long-term stability and predictability in correcting myopia, with 68.8% of eyes within 1.0 diopter of the intended correction after 10 years.

The procedure was found to be safe, with minimal corneal endothelial cell loss (mean -8.86%) and no significant long-term glare reported, while 93.3% of patients achieved a best-corrected visual acuity of 20/40 or better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term study of Artisan phakic intraocular lens implantation for the correction of moderate to high myopia: ten-year follow-up results. Tahzib, NG., Nuijts, RM., Wu, WY., et al.[2022]

Phakic intraocular lens (pIOL) implantation significantly improved vision in patients with high myopia, with the mean spherical equivalent decreasing from -18.32 diopters to -0.88 diopters after 5 years, and over 50% of eyes achieving 20/25 vision or better.

The procedure demonstrated good safety and predictability, with a safety index of 1.26 and minimal serious complications; only two eyes developed cataracts, and only one required surgery, indicating that the pIOL is a viable long-term solution for high myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year functional outcomes and vault of -20 diopter myopic phakic intraocular lens implantation. Lisa, C., Baamonde, B., Pérez-Vives, C., et al.[2017]

In a study involving 20 patients, the implantation of phakic refractive lenses (PRLs) for correcting myopia and hyperopia showed high safety and efficacy, with 25% of eyes gaining 2 or more lines of best spectacle-corrected visual acuity (BSCVA) and no eyes losing significant vision over a 2-year follow-up.

The study found that the distance between the PRL and the crystalline lens decreased significantly in the first year but stabilized thereafter, and there were no significant adverse effects like induced cataracts or glaucoma, although some patients experienced minor complications such as pupillary block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic refractive lens: two-year results. Koivula, A., Taube, M., Zetterström, C.[2022]

In a study of 40 eyes from 25 patients, the implantation of a phakic intraocular lens (pIOL) for hyperopia showed high refractive stability, with 87.5% of eyes within +/-1.00 diopter of emmetropia after one year.

The most common complication was postoperative pupillary block in 17.5% of cases, but there were no cases of pIOL-induced glaucoma or cataract, indicating a relatively safe profile for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic intraocular lens for the correction of hyperopia. Koivula, A., Zetterström, C.[2009]

Phakic intraocular lens (pIOL) implantation is an effective method for correcting myopia and myopic astigmatism, with FDA trials showing that a significant percentage of patients achieved uncorrected visual acuity of 20/40 or better after 3 years.

Compared to LASIK and refractive lens exchange, pIOLs offer better visual acuity and stability, particularly for patients with high myopia (greater than -8 diopters), while also presenting a lower risk of retinal detachment, although careful monitoring for potential complications is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic intraocular lens implantation for the correction of myopia: a report by the American Academy of Ophthalmology. Huang, D., Schallhorn, SC., Sugar, A., et al.[2022]

Recent clinical trials, including FDA studies, have demonstrated that phakic intraocular lenses provide predictable, stable, and effective refractive correction for vision problems.

While the long-term safety of phakic intraocular lenses is still a concern, they are increasingly being recognized as a preferred option for refractive correction in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic intraocular lenses. Comaish, IF., Lawless, MA.[2019]

Phakic intraocular lens implantation has become a common and effective treatment for myopia and astigmatism, now being used for a wider range of myopia levels, including low myopia.

To ensure the safety and effectiveness of this procedure, there is a need for standardized practices in lens implantation and improved quality control to minimize surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strengthening the safety of phakic intraocular lens implantation for myopia and astigmatism]. Zhang, FJ., Li, Y., Xiong, Y.[2021]

The Ziemer DaVinci system offers low laser pulse energy, which reduces bubble formation during the cutting process, leading to more precise cuts, although its compact design limits flexibility in cutting geometry.

The IntraLase FS laser has the most clinical experience, enhancing its safety and technical support, but it relies on older technology that is sensitive to environmental changes, unlike the newer Zeiss VisuMax system, which is more robust but bulkier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of commercially available femtosecond lasers in refractive surgery. Lubatschowski, H.[2019]

Femtosecond lenticule extraction (FLE) was successfully performed on 10 myopic eyes, with significant improvement in vision from a mean spherical equivalent of -4.73 D preoperatively to -0.33 D after 6 months, indicating its efficacy in correcting myopia.

All patients reported high satisfaction with the procedure, and there were no significant complications, such as loss of vision or increased higher-order aberrations, suggesting that FLE is a safe and promising method for refractive correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results. Sekundo, W., Kunert, K., Russmann, C., et al.[2022]

Both the Russian (1 MHz) and Swiss (5 MHz) femtosecond laser platforms used in the FemtoLASIK procedure were found to be effective and safe for treating low to moderate myopia, with over 90% of patients achieving uncorrected visual acuity of 1.0 or better after 12 months.

There were no significant differences in visual outcomes or predictability between the two laser platforms, indicating that both methods provide similar stability and effectiveness in refractive surgery, despite a slight increase in corneal higher-order aberrations post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and functional outcomes of correcting low to moderate myopia with FemtoLASIK performed with Russian and Swiss femtolaser platforms]. Doga, AV., Mushkova, IA., Karimova, AN., et al.[2020]

Femtosecond laser technology in ophthalmology enhances the precision and reproducibility of corneal surgeries, such as lamellar and penetrating keratoplasties, by allowing for micrometric cuts in any direction.

While the technology improves surgical efficiency and aims to reduce complications like astigmatism, the long-term visual benefits of femtosecond lasers in these procedures still need further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Femtosecond laser-assisted keratoplasties]. Chastang, P., Hoang-Xuan, T.[2019]

Femtosecond laser technology can create precise cuts in biological lenses with minimal damage to surrounding tissue, as demonstrated in a study involving 150 pig lenses and 4 rabbit lenses.

The treatment showed no cataract formation and maintained lens clarity for 3 months in rabbits, indicating its potential safety and efficacy for treating presbyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[In vitro and in vivo investigations on the treatment of presbyopia using femtosecond lasers]. Gerten, G., Ripken, T., Breitenfeld, P., et al.[2019]

References

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

Long-term results of phakic refractive lens implantation in eyes with high myopia. [2011]

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

Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 diopters: 1-year follow-up. [2019]

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

Phakic refractive lens experience in Spain. [2019]

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

Long-term study of Artisan phakic intraocular lens implantation for the correction of moderate to high myopia: ten-year follow-up results. [2022]

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

Five-year functional outcomes and vault of -20 diopter myopic phakic intraocular lens implantation. [2017]

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

Phakic refractive lens: two-year results. [2022]

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

Phakic intraocular lens for the correction of hyperopia. [2009]

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

Phakic intraocular lens implantation for the correction of myopia: a report by the American Academy of Ophthalmology. [2022]

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

Phakic intraocular lenses. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Strengthening the safety of phakic intraocular lens implantation for myopia and astigmatism]. [2021]

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

Overview of commercially available femtosecond lasers in refractive surgery. [2019]

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

First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results. [2022]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical and functional outcomes of correcting low to moderate myopia with FemtoLASIK performed with Russian and Swiss femtolaser platforms]. [2020]

14. France pubmed.ncbi.nlm.nih.gov

[Femtosecond laser-assisted keratoplasties]. [2019]

15. Germany pubmed.ncbi.nlm.nih.gov

[In vitro and in vivo investigations on the treatment of presbyopia using femtosecond lasers]. [2019]