Hydrus Learning Curve Study

January 7, 2026 updated by: Craig Chaya, University of Utah

Learning Curve Associated With Hydrus Microstent Implantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fellows
Glaucoma surgical fellows with minimal surgical experience
Other: Surgical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Craig Chaya, MD, University of Utah John A. Moran Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 180462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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