SurgeryNCT06964139
Hydrus Learning Curve Study
An observational study of Surgery and Surgical Procedures, Minimally Invasive, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Surgical Procedures, Minimally Invasive, Training
- What is being tested?
- Surgical video grading
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Glaucoma fellow at the Moran Eye Center, Washington University or Baylor University
Who may be able to join
- Current glaucoma fellow at the Moran Eye Center, Washington University or Baylor University
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132
About this study
Official title: 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.
- Conditions
- Surgery, Surgical Procedures, Minimally Invasive, Training, Training Effectiveness, Learning Curve
- Being tested
- Surgical video grading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical video gradingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fellows | Glaucoma surgical fellows with minimal surgical experience Receives: Other: Surgical video grading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start12 Dec 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Craig Chaya, University of Utah
- Investigators
- Craig Chaya, MD, Principal investigator, University of Utah John A. Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964139
- Sponsor's protocol ID
- 180462
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve Associated With Hydrus Microstent Implantation
- ClinicalTrials.gov ID
- NCT06964139
- Acronym / sponsor ID
- 180462
- Conditions
- Surgery, Surgical Procedures, Minimally Invasive, Training, Training Effectiveness, Learning Curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fellows | – | Other: Surgical video gradingGlaucoma surgical fellows with minimal surgical experience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Glaucoma fellow at the Moran Eye Center, Washington University or Baylor University
Key inclusion criteria (1 listed)
- Current glaucoma fellow at the Moran Eye Center, Washington University or Baylor University
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical video gradingVideos 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. | Other | Fellows |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Surgery
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
RecruitingPhase 3
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
Oral Cavity Carcinoma, Flap
RecruitingEarly Phase 1
Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Chaya, MD principal investigator
University of Utah John A. Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Surgical Procedures, Minimally Invasive, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.