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NCT05264623 · ClinicalTrials.gov registry record · 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

A NA study of Hyperopia, sponsored by Bausch & Lomb Incorporated.

Active
Registry status
NA
Development phase
140
Enrollment target
9
Study locations

NCT05264623 is a NA study of Hyperopia that is active but no longer recruiting, run by Bausch & Lomb Incorporated. The registered enrollment target is 140 participants, above the 110-participant average among 10 other Hyperopia trials with a reported enrollment target (27% higher). The trial reports 9 study locations across 8 states.

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The verdict

NCT05264623, a NA study of Hyperopia, is active but no longer recruiting, sponsored by Bausch & Lomb Incorporated.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
140 participants
Enrollment target
9
Study locations

Study 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.

Conditions Studied

Hyperopia

Interventions

  • DEVICE TENEO 317 Model 2 excimer laser

Study Locations (9)

Minnesota

  • Site 101 - Bloomington
  • Site 104 - Saint Louis Park

California

  • Site 113 - Newport Beach

Florida

  • Site 111 - Fort Myers

Nebraska

  • Site 103 - Omaha

New York

  • Site 102 - Amherst

Pennsylvania

  • Site 112 - Pittsburgh

South Dakota

  • Site 108 - Sioux Falls

Texas

  • Site 106 - Cedar Park

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2022-11-15
Est. Completion 2026-11-20
Phase NA

Sponsor

Bausch & Lomb Incorporated

174 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05264623

The ClinicalTrials.gov registry entry for NCT05264623 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 10 other Hyperopia trials with a reported enrollment target (27% higher). The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hyperopia appearing as the primary indexed condition, and to 1 intervention - of which TENEO 317 Model 2 excimer laser is the first listed.

NCT05264623 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Minnesota, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05264623 about?

NCT05264623 is a clinical study titled "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". 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. B...

What is the current status of trial NCT05264623?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2022-11-15. Estimated completion is 2026-11-20.

What conditions does trial NCT05264623 study?

This clinical trial studies the following conditions: Hyperopia.

What interventions are being tested in trial NCT05264623?

The interventions under investigation include: TENEO 317 Model 2 excimer laser (DEVICE).

Who is sponsoring clinical trial NCT05264623?

This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05264623 being conducted?

This trial has 9 study locations across California, Florida, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.