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Excimer Laser

TENEO 317 Model 2 excimer laser for Farsightedness

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
Agree to emmetropia correction for each treated eye
Anticipated postoperative stromal bed thickness of at least 250 microns
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to have my vision corrected to normal.
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My eye surgery will leave a thick enough layer in my eye.
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My vision prescription has been stable after I stopped wearing contact lenses.

Timeline

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

Find a Location

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
251 Previous Clinical Trials
57,276 Total Patients Enrolled
Anya LoncaricStudy DirectorBausch & Lomb Incorporated
39 Previous Clinical Trials
20,691 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant headcount in this clinical experiment?

"To properly conduct this experiment, the sponsor, Bausch & Lomb Incorporated, needs to enrol 140 eligible patients. This trial will be conducted in two distinct locations: Saint Louis Park's Bausch Site 104 and Amherst's Bausch Site 102."

Answered by AI

Are new participants still being enrolled in this research endeavor?

"According to the data hosted on clinicaltrials.gov, this study is actively seeking participants after being initially listed on June 30th of 2022 with its most recent update occurring in September of that same year."

Answered by AI

In how many health care facilities are the protocols associated with this trial being implemented?

"Multiple sites are contributing to this medical experiment, including Bausch Site 104 in Saint Louis Park, New york; Bausch Site 102 in Amherst, North carolina; and Bausch Site 107 in Greensboro, New hampshire. Other locations are also involved."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Bausch Site 107
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

What questions have other patients asked about this trial?

How long do screening visits last?
PatientReceived 2+ prior treatments
~61 spots leftby May 2025