Hydrus Learning Curve Study

NCT ID: NCT06964139

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-07-15

Brief Summary

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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

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Conditions

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Surgery Surgical Procedures, Minimally Invasive Training Training Effectiveness Learning Curve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fellows

Glaucoma surgical fellows with minimal surgical experience

Surgical video grading

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Craig Chaya

Assistant Professor (Clinical)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Chaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah John A. Moran Eye Center

Locations

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University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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180462

Identifier Type: -

Identifier Source: org_study_id

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