What side effects are associated with this type of intervention?

Common treatments for farsightedness, such as LASIK using excimer lasers like the TECHNOLAS TENEO 317 Model 2, can have several side effects. These may include dry eyes, glare, halos around lights, under-correction or over-correction of vision, and in rare cases, infection or flap complications. Some patients may also experience temporary discomfort or visual disturbances during the healing process. It is important to discuss these potential risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several excimer lasers for the treatment of farsightedness (hyperopia) by reshaping the cornea to correct refractive errors. These include devices like the VISX STAR S4 IR Excimer Laser System and the Alcon LADARVision 4000 Excimer Laser System. These lasers use precise ultraviolet light to remove corneal tissue and improve the eye's focusing ability. The TECHNOLAS TENEO 317 Model 2 excimer laser is another such device currently being studied for its safety and effectiveness in treating hyperopia with or without astigmatism.

What other types of research exist?

Promising alternatives to the TECHNOLAS TENEO 317 Model 2 excimer laser for treating farsightedness include: 1) SMILE (Small Incision Lenticule Extraction) which uses a femtosecond laser to create a lenticule within the cornea that is then removed through a small incision, 2) PRK (Photorefractive Keratectomy) which involves reshaping the cornea's surface using an excimer laser, and 3) Phakic IOLs (Intraocular Lenses) which are implanted in the eye to correct refractive errors without altering the cornea. These options provide effective alternatives for patients seeking refractive correction.

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Excimer Laser

Laser Surgery for Farsightedness and Astigmatism

Q: What is the mechanism of action of this treatment?

The most common treatment for farsightedness, such as the one studied with the TECHNOLAS TENEO 317 Model 2 excimer laser, involves reshaping the cornea using laser technology. The excimer laser precisely removes microscopic amounts of corneal tissue to flatten the cornea, thereby improving the eye's ability to focus light directly onto the retina. This correction of the corneal shape reduces or eliminates the refractive error that causes farsightedness. For patients, this means clearer vision without the need for corrective lenses, significantly improving their quality of life and daily functioning.

N/A

Recruiting

Research Sponsored by Bausch & Lomb Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Summary

This trial will study the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 excimer laser for LASIK surgery to treat hyperopia with or without hyperopic astigmatism.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed in your information provided above; generally speaking LASIK surgery side effects may include discomfort or pain post-surgery, visual disturbances such as glare and halos around lights especially at night which usually improve over time but could persist long-term.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eye

Trial Design

1Treatment groups

Experimental Treatment

Group I: TENEO 317 Model 2 excimer laserExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for farsightedness, such as the one studied with the TECHNOLAS TENEO 317 Model 2 excimer laser, involves reshaping the cornea using laser technology. The excimer laser precisely removes microscopic amounts of corneal tissue to flatten the cornea, thereby improving the eye's ability to focus light directly onto the retina. This correction of the corneal shape reduces or eliminates the refractive error that causes farsightedness. For patients, this means clearer vision without the need for corrective lenses, significantly improving their quality of life and daily functioning.

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor

252 Previous Clinical Trials

57,197 Total Patients Enrolled

Anya LoncaricStudy DirectorBausch & Lomb Incorporated

39 Previous Clinical Trials

20,523 Total Patients Enrolled

~47 spots leftby May 2025

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