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OpenTrials
Completed

NCT Number: NCT06964139

Hydrus Learning Curve Study

The goal of this observational study is to better understand the learning curve among novice glaucoma surgeons performing Hydrus microstent insertion. The main question it aims to answer is what is the average number of cases does it take new glaucoma surgical fellows to become competent in Hydrus insertion. Researchers will review and grade videos of surgical cases. Participating fellows will complete a survey reporting the number of cases they had completed before beginning their glaucoma surgical fellowship and how many Hydrus cases they performed during their fellowship before they felt comfortable performing Hydrus cases without an attending surgeon overseeing their work.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current glaucoma fellow at the Moran Eye Center, Washington University or Baylor University

Exclusion criteria

  • None

Treatment and study plan

Surgical video grading

Other

Videos of fellow surgical cases will be randomized in sequence and provided to a masked grader who will review cases and record primary and secondary endpoints.

Primary outcomes

  1. Mean number of cases across all fellows needed to achieve and maintain at least an 80% competence score

    Time frame: through study completion, an average of 9 months

    The competency matrix for Hydrus follows recommended surgical procedural steps. There are 12 competency steps that will be scored on a scale of 1-Novice to 4-Competent, for a total of 48 points. A score of 39 (80%) is considered competent.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Learning Curve Associated With Hydrus Microstent Implantation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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