Hydrus Learning Curve Study

Active, not recruiting

• Conditions: Surgery; Surgical Procedures, Minimally Invasive; Training; Training Effectiveness; Learning Curve

• Registration Number: NCT06964139
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-12
• Study First Submitted: 2025-03-21
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah John A. Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States