ELITA System for Refractive Errors

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ELITA system, a femtosecond laser system, to determine its safety and effectiveness in correcting vision problems like nearsightedness (myopia) and astigmatism, which cause blurry vision. Participants will undergo a special procedure on one eye and a common laser treatment on the other to compare results. It suits individuals struggling with blurry vision due to myopia or astigmatism who have tried glasses or contacts but seek a more lasting solution. As an unphased trial, it provides a unique opportunity to explore innovative solutions for vision correction.

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 prior data suggests that the ELITA System is safe for treating refractive errors?

Research shows that the ELITA System, which uses a special laser, safely treats vision problems like nearsightedness and astigmatism (a curvature issue in the eye). Studies have found that patients tolerate this laser procedure well, with no serious side effects reported. The treatment uses a method called SILK, where a small part of the eye's surface is gently removed to improve vision. Overall, evidence suggests that the ELITA System is a safe choice for correcting vision issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ELITA System because it offers a novel approach to correcting refractive errors like myopia. Unlike traditional laser vision correction methods, which reshape the cornea using lasers, the ELITA System uses a technique called SILK lenticule removal. This method involves removing a thin layer of corneal tissue, called a lenticule, to alter the eye's focusing power. This procedure could potentially offer more precise corrections with less impact on the surrounding corneal tissue, leading to quicker recovery times and better outcomes for patients.

What evidence suggests that the ELITA System is effective for refractive errors?

Research shows that the ELITA System effectively treats nearsightedness, which impairs the ability to see distant objects. In earlier studies, the SILK procedure using the ELITA Femtosecond Laser System proved safe and effective, even for individuals with astigmatism, a condition causing blurred vision. During the Feasibility Phase, participants will undergo the SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on the other. The system operates efficiently and predictably, reliably correcting vision. This instills confidence that the ELITA System can enhance eyesight for those with these common vision issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Johnson & Johnson Surgical Vision, Inc. Clinical Trials

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10715007/

Safety and Effectiveness of Smooth Incision Lenticular ... The SILK procedure with the ELITA Femtosecond Laser System is safe and effective for the treatment of myopic refractive errors with and without astigmatism.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38089649/

Safety and Effectiveness of Smooth Incision Lenticular ... The SILK procedure with the ELITA Femtosecond Laser System is safe and effective for the treatment of myopic refractive errors with and without astigmatism.

3. dovepress.com dovepress.com/evaluation-of-higher-order-aberrations-after-the-smooth-incision-lenti-peer-reviewed-fulltext-article-OPTH

Evaluation of SILK procedure using ELITA platform | OPTH This study has demonstrated that the SILK procedure using ELITA femtosecond laser system is efficient and predictable for the correction of ...

4. nature.com nature.com/articles/s41598-025-13957-6

An objective assessment of vision performance at different ... ELITA™ is the latest new generation ophthalmic femtosecond laser surgical system developed by Johnson and Johnson Surgical Vision, Inc. ( ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05713253

Study Details | NCT05713253 | A PHASED ... Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will ...

6. med.stanford.edu med.stanford.edu/eyelaser/CurrentClinicalTrials/Elita.html

Elita Laser Vision Correction - Stanford Medicine The primary objective of this study is to evaluate the safety and efficacy of small incision lenticule surgery using the Johnson and Johnson Elita Femtosecond ...

7. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S481676

Full article: Safety and Effectiveness of Smooth Incision ... I was interested to read the paper by Sachdev et al on the safety and effectiveness of the ELITA™ femtosecond laser for astigmatic corrections.