Laser Surgery for Farsightedness and Astigmatism

Not currently recruiting at 17 trial locations

Overseen By Dennis Carson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bausch & Lomb Incorporated

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

Disqualifiers: Diabetes, Glaucoma, Cataract, 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: 13

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser system, the TENEO 317 Model 2, to evaluate its safety and effectiveness for LASIK eye surgery in treating farsightedness (difficulty seeing up close) and astigmatism (blurry vision due to an irregularly shaped cornea). The goal is to improve vision without the need for glasses or contact lenses. Individuals who have struggled to maintain clear distance vision without corrective lenses and have had stable vision prescriptions for at least a year might be suitable for this study. Participants must also agree to stop wearing contact lenses for a specified period before the surgery. As an unphased trial, this study offers a unique opportunity to contribute to advancing LASIK technology and potentially improve vision.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications that could increase risk or affect the study's outcome, such as those affecting wound healing or contraindicated with LASIK, like isotretinoin or amiodarone hydrochloride.

What prior data suggests that the TENEO 317 Model 2 excimer laser is safe for LASIK surgery?

Research has shown that the TENEO 317 Model 2 excimer laser is safe for LASIK surgery. In past studies, researchers found no unexpected safety issues with this laser, meaning it performed as expected without causing surprise side effects. The FDA has approved the TENEO 317 Model 2 for correcting nearsightedness, indicating it meets safety standards for that purpose.

Overall, current evidence suggests that this laser is well-tolerated for LASIK, making it a promising option for treating farsightedness and astigmatism. Prospective participants should discuss any concerns with their healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TENEO 317 Model 2 excimer laser is unique because it uses advanced laser technology to precisely reshape the cornea, which can improve vision for people with farsightedness and astigmatism. Unlike traditional methods such as glasses, contact lenses, or older laser surgery techniques, this treatment offers a more personalized and potentially faster recovery process. Researchers are excited because the precision of the excimer laser may lead to better visual outcomes and increased patient satisfaction compared to existing options.

What evidence suggests that the TENEO 317 Model 2 excimer laser is effective for treating farsightedness and astigmatism?

Research has shown that the Technolas Teneo 317 Model 2 laser, which participants in this trial will receive, effectively aids LASIK surgery by correcting vision problems such as farsightedness and astigmatism. Studies have found that this laser safely reshapes the cornea (the eye's outer layer) to focus light correctly onto the retina. Patients who have used this technology often experience improved vision, with many achieving 20/20 vision. This laser has been successfully used for similar vision corrections, supporting its effectiveness for the condition under study in this trial. ^{1 2 3 4 6}

Who Is on the Research Team?

Rosangela Nolasco

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

This trial is for people aged 22 or older with stable farsightedness (+1.00 to +4.00 D) and astigmatism (up to +2.00 D), who've had a consistent prescription for at least a year, can lie flat without trouble, and have good corrected vision (20/25 or better). They must not be in other trials, sensitive to LASIK meds, have certain eye conditions like keratoconus or scars, large pupils (>7 mm), dry eyes (Schirmer's test <4mm), glaucoma risks, previous eye surgeries that affect results, muscle disorders affecting the eyes, significant cataracts, take meds that interfere with healing or are pregnant.

Inclusion Criteria

I agree to stop wearing my contact lenses before my eye test and surgery as required.

I can lie flat without any problems.

Willing and able to read, understand, and sign a written informed consent form (ICF)

Exclusion Criteria

I do not have any health conditions that could affect the study's safety or results.

I am not on medications that could interfere with the study or my healing.

Ocular conditions, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to: Evidence or history of retinal vascular disease, History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye, History of or evidence of glaucoma or glaucoma suspect (IOP > 24 mmHg), Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the outcome of the study or increase the risk to the subject, An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation, Known sensitivity to any study medications (e.g., used during LASIK procedure and postoperative care), Have central corneal scars affecting visual acuity, Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism), Presence of visually significant or progressive cataract in an eye considered for eligibility, Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone), Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, Pregnant, lactating, or subjects who plan to become pregnant during the course of the study, Are participating in any other trial within 30 days of screening or during this clinical trial, Eyes with mesopic pupil size > 7.0 mm, Have a Schirmer's pre-operative test without anesthesia < 4 mm/5 minutes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo LASIK surgery using the TENEO 317 Model 2 excimer laser to treat hyperopia with or without astigmatism

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after LASIK surgery

12 months

Multiple visits (in-person) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• TENEO 317 Model 2

Trial Overview The study tests the safety and effectiveness of the TENEO 317 Model 2 excimer laser for LASIK surgery on those with hyperopia (farsightedness) with/without astigmatism over a period of 12 months. It's an open-label study where all participants receive treatment using this specific laser technology.

How Is the Trial Designed?

Group I: TENEO 317 Model 2 excimer laser Experimental Treatment 1 Intervention

TENEO 317 Model 2 is already approved in European Union, United States for the following indications:

Approved in European Union as TECHNOLAS TENEO 317 Model 2 for:

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Approved in United States as TECHNOLAS TENEO 317 Model 2 for:

• Myopia with or without astigmatism
• Hyperopia with or without astigmatism

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

Published Research Related to This Trial

In a study comparing 43 eyes receiving the Visian Toric Implantable Collamer Lens (TICL) and 45 eyes undergoing photorefractive keratectomy (PRK), the TICL showed significantly better outcomes in best spectacle-corrected visual acuity (BSCVA) and uncorrected visual acuity (UCVA) at all postoperative time points, indicating superior safety and efficacy.

The TICL also demonstrated better predictability and stability of refraction compared to PRK, making it a promising alternative for correcting moderate to high myopic astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized prospective comparison of visian toric implantable collamer lens and conventional photorefractive keratectomy for moderate to high myopic astigmatism. Schallhorn, S., Tanzer, D., Sanders, DR., et al.[2022]

The Teneo 317 M2 platform using the myopic Supracor algorithm demonstrated high efficacy in treating myopia and presbyopia, with 96% of patients achieving 20/25 vision or better after 12 months.

The procedure was found to be safe, with only 2% of eyes requiring revision surgery and a low incidence of visual acuity loss, indicating that Supracor is a viable alternative to traditional monovision techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presbyopic LASIK using the Supracor algorithm and micromonovision in presbyopic myopic patients: 12-month visual and refractive outcomes. Adam, T., Boucenna, W., Lussato, M., et al.[2023]

LASIK surgery using the NIDEK EC-5000 excimer laser effectively reduced hyperopic astigmatism in 46 eyes, with a significant improvement in uncorrected visual acuity from 20/100 preoperatively to 20/30 at 24 months post-surgery.

While LASIK is generally safe, with only 4.3% of eyes experiencing complications, there is a notable early regression of astigmatic correction within the first 6 months, which stabilizes by the one-year mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LASIK using the NIDEK EC-5000 for the correction of hyperopic astigmatism. Ismail, MM.[2022]

The study compared the visual quality of a simulated Toric Implantable Collamer Lens (TICL) and a bioptics technique for treating high myopic astigmatism, finding that TICL provided better visual acuity and contrast sensitivity, especially with larger pupil sizes.

Statistically significant differences indicated that TICL had superior optical performance, with less spread in the Point Spread Function (PSF) and better Modulation Transfer Function (MTF) results compared to the bioptics technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myopic astigmatism correction: comparison of a Toric Implantable Collamer Lens and a bioptics technique by an adaptive optics visual simulator. Pérez-Vives, C., Domínguez-Vicent, A., Madrid-Costa, D., et al.[2013]

Recent advancements in hyperopic refractive surgery, particularly with photorefractive keratectomy and laser in situ keratomileusis, have significantly improved efficacy, making them viable options for correcting hyperopia up to 4 or 5 diopters.

While newer techniques like laser thermal keratoplasty and phakic intraocular lenses show promise, safety concerns remain, highlighting the ongoing challenges in effectively treating hyperopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperopic refractive surgery. Sher, NA.[2022]

The toric implantable collamer lens is designed to effectively treat high levels of myopic astigmatism, accommodating refractive errors up to -18 diopters and +1 to +6 diopters of astigmatism, which is a significant advancement over traditional treatments.

The latest model of the toric implantable collamer lens features a small central hole that enhances safety by eliminating the need for an iridectomy or iridotomy, making the surgical procedure less invasive and reducing potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the toric implantable collamer lens for simultaneous treatment of myopia and astigmatism. Price, MO., Price, FW.[2014]

LASIK is an effective refractive surgery option for correcting myopia up to -8 D, hyperopia up to +3 D, and astigmatism up to 5 D, making it suitable for a wide range of vision correction needs.

For higher refractive errors beyond the limits of LASIK, such as myopia greater than -6 D and hyperopia greater than +3 D, phakic intraocular lenses (IOL) are recommended as the first choice, with refractive lens exchange being an alternative for patients with presbyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current state of refractive surgery of the cornea and lens]. Knorz, MC.[2021]

In a study of 216 eyes treated with the Technolas 217A excimer laser for myopia and myopic astigmatism, the achieved refractive correction at 6 months was very close to the attempted correction, indicating the procedure's efficacy.

The size of the optical zone significantly influenced outcomes, with a 9% difference in effectiveness between 4 mm and 7 mm zones, suggesting that adjustments in treatment parameters could optimize results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nomogram considerations with the Technolas 217A for treatment of myopia. Anderson, NJ., Hardten, DR., Davis, EA., et al.[2022]

A study analyzing approximately 5700 eyes treated with LASIK for myopia and astigmatism showed that both the Nidek EC-5000 and Meditec Mel 70 lasers provided effective refractive outcomes, with early stability observed in both groups.

At 6 months post-surgery, the Nidek EC-5000 group had a mean spherical equivalent of -0.24 D with 72% of eyes within +/- 0.50 D, while the Meditec group had a mean of -0.54 D with 55% within the same range, but the Meditec group experienced higher rates of complications like epithelial ingrowth and haze.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of laser in situ keratomileusis outcomes with the Nidek EC-5000 and Meditec Mel 70 excimer lasers. Merchea, M., Pieger, S., Bains, HS.[2022]

In a study of 80 eyes from 40 patients aged 42 to 66, hyperopic presbyopic LASIK using the TENEO 317 algorithm resulted in stable and acceptable visual outcomes after 24 months, with excellent uncorrected distance visual acuity in the dominant eye (20/20) and reasonable near visual acuity.

While most patients experienced good results, 2.5% of non-dominant eyes lost two lines of corrected distance visual acuity, indicating some risk of visual acuity loss, but overall, the procedure was deemed effective and predictable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractive and Visual Outcomes of SUPRACOR TENEO 317 LASIK for Presbyopia in Hyperopic Eyes: 24-Month Follow-up. Sánchez-González, JM., Alonso-Aliste, F., Amián-Cordero, J., et al.[2020]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P990027S021D.pdf

PROFESSIONAL USE INFORMATION - accessdata.fda.gov The study was a multicenter, prospective, open-label, nonrandomized, single-arm study evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 MODEL2 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39120020/

Safety and Effectiveness of Laser in Situ Keratomileusis ... LASIK performed using a new aspheric ablation profile of the Technolas Teneo 317 (Model 2) excimer laser is safe and effective for correcting myopia and myopic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04111757

A Study With Technolas® TENEO 317 Model 2 Excimer ... The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in ...

4. bauschsurgical.eu bauschsurgical.eu/fileadmin/user_upload/TENEO_M2_BROCHURE.PDF

Technolas® TENEOTM 317 Model 2 (M2) The TENEO™ 317 M2 features a 60° swivelling patient bed. Ergonomically designed with contours following the natural shape of the spine and a wide mattress ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P990027S021B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The study was a multicenter, prospective, open-label, nonrandomized, single-arm study evaluating the safety and effectiveness of the TENEO 317 ( ...

6. ir.bausch.com ir.bausch.com/press-releases/bausch-lomb-receives-fda-approval-teneotm-excimer-laser-platform-myopia-and-myopic

Bausch + Lomb Receives FDA Approval for TENEO™ ... The Technolas Teneo 317 Model 2 is indicated for laser-assisted in situ keratomileusis (LASIK) in: (1) Patients for the reduction or elimination ...