Hydrus Learning Curve Study

NCT06964139 | Completed FDA Device

• 1 other identifier: 180462
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Surgical Procedures, Minimally Invasive; Training; Training Effectiveness; Learning Curve

Outcome Measures

Primary Outcomes (1)

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

  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.

  through study completion, an average of 9 months

Study Arms (1)

Fellows

Glaucoma surgical fellows with minimal surgical experience

Other: Surgical video grading

Interventions

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.

Fellows

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma fellow at the Moran Eye Center, Washington University or Baylor University

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Utah: lead
• Alcon Research: collaborator

Study Sites (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Study Officials

• Craig Chaya, MD

  University of Utah John A. Moran Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: May 9, 2025
• Study Start: December 12, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)