CClinicalTrials.gg
CompletedNCT06964139Updated Jan 9, 2026

Hydrus Learning Curve Study

An observational study in Surgery, Surgical Procedures, Minimally Invasive and Training, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Surgical Procedures, Minimally Invasive
  • Training
  • Training Effectiveness
  • Learning Curve
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • Fellows

    Glaucoma surgical fellows with minimal surgical experience

    Other: Surgical video grading

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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • University of Utah John A. Moran Eye Center
    Salt Lake City, Utah 84132, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06964139
Lead sponsor
University of Utah
Collaborators
Alcon Research
Responsible party
Craig Chaya (Assistant Professor (Clinical), University of Utah) — Principal investigator
First posted
May 9, 2025
Start date
Dec 12, 2024
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025
Last update
Jan 9, 2026

Study contacts

Craig Chaya, MD
principal investigator · University of Utah John A. Moran Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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