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Hydrus Learning Curve Study

Learning Curve Associated With Hydrus Microstent Implantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06964139
Enrollment
5
Registered
2025-05-09
Start date
2024-12-12
Completion date
2025-07-15
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERSurgical video grading

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.

Sponsors

Alcon Research
CollaboratorINDUSTRY
University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Mean number of cases across all fellows needed to achieve and maintain at least an 80% competence scorethrough study completion, an average of 9 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026