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ACTIVE NOT RECRUITING
NCT05264623
NA

Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

Sponsor: Bausch & Lomb Incorporated

View on ClinicalTrials.gov

Summary

This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.

Official title: A Study to Investigate the Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2022-11-15

Completion Date

2026-11-20

Last Updated

2026-01-23

Healthy Volunteers

No

Conditions

Interventions

DEVICE

TENEO 317 Model 2 excimer laser

TENEO 317 Model 2 excimer laser use for refractive surgery

Locations (9)

Site 113

Newport Beach, California, United States

Site 111

Fort Myers, Florida, United States

Site 101

Bloomington, Minnesota, United States

Site 104

Saint Louis Park, Minnesota, United States

Site 103

Omaha, Nebraska, United States

Site 102

Amherst, New York, United States

Site 112

Pittsburgh, Pennsylvania, United States

Site 108

Sioux Falls, South Dakota, United States

Site 106

Cedar Park, Texas, United States