Laser Surgery for Farsightedness and Astigmatism

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Bausch & Lomb Incorporated

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

Disqualifiers: Diabetes, Glaucoma, Cataract, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a special laser machine for eye surgery on patients with farsightedness. The laser reshapes the eye's surface to improve their 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 data supports the effectiveness of the treatment TENEO 317 Model 2 for farsightedness and astigmatism?

Research shows that the TENEO 317 platform is effective for improving vision in people with presbyopia (age-related difficulty in seeing close objects) and hyperopia (farsightedness), suggesting it may also be effective for treating farsightedness and astigmatism. ^{1 2 3 4 5}

How does the TENEO 317 Model 2 treatment for farsightedness and astigmatism differ from other treatments?

The TENEO 317 Model 2 treatment is a type of laser surgery that uses advanced technology to correct farsightedness and astigmatism, potentially offering more precise and effective results compared to older methods like photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). This treatment may provide a more tailored approach to correcting vision by using large diameter laser ablations and improved keratomes, which can be beneficial for patients with specific refractive errors. ^{6 7 8 9 10}

Research Team

Rosangela Nolasco

Principal Investigator

Bausch & Lomb Incorporated

Eligibility Criteria

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 agree to have my vision corrected to normal.

My eyesight prescription has been stable for at least 12 months.

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

Trial Timeline

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

Treatment Details

Interventions

• TENEO 317 Model 2 (Excimer Laser)

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.

Participant Groups

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

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

Findings from Research

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 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]

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]

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]

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]

References

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

Comparison of laser in situ keratomileusis outcomes with the Nidek EC-5000 and Meditec Mel 70 excimer lasers. [2022]

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

Nomogram considerations with the Technolas 217A for treatment of myopia. [2022]

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

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

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

Refractive and Visual Outcomes of SUPRACOR TENEO 317 LASIK for Presbyopia in Hyperopic Eyes: 24-Month Follow-up. [2020]

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

Presbyopic LASIK using the Supracor algorithm and micromonovision in presbyopic myopic patients: 12-month visual and refractive outcomes. [2023]

6. England 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. [2013]

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

Randomized prospective comparison of visian toric implantable collamer lens and conventional photorefractive keratectomy for moderate to high myopic astigmatism. [2022]

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

Hyperopic refractive surgery. [2022]

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

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

10. England pubmed.ncbi.nlm.nih.gov

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