TENEO 317 Model 2 excimer laser for Hyperopia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hyperopia+1 More
TENEO 317 Model 2 excimer laser - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Hyperopia

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
Eye

Trial Safety

Trial Design

1 Treatment Group

TENEO 317 Model 2 excimer laser
1 of 1
Experimental Treatment

140 Total Participants · 1 Treatment Group

Primary Treatment: TENEO 317 Model 2 excimer laser · No Placebo Group · N/A

TENEO 317 Model 2 excimer laser
Device
Experimental Group · 1 Intervention: TENEO 317 Model 2 excimer laser · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
235 Previous Clinical Trials
54,726 Total Patients Enrolled
1 Trials studying Hyperopia
80 Patients Enrolled for Hyperopia
Anya LoncaricStudy DirectorBausch Health Americas, Inc.
38 Previous Clinical Trials
20,599 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a manifest refractive error of < 0.75 D.
You are 22 years of age or older at the time of the pre-operative examination.
You have a manifest, distance best spectacle corrected visual acuity of 20/25 (logMAR 0.
You have hyperopia with or without cylinder up to +2.00 D, based on the manifest refraction in the study eye(s).
You are willing to have your eyes corrected for refractive error.
The stromal bed thickness of the postoperative stroma must be at least 250 microns.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.