- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06964139
Hydrus Microstent Implantation Learning Curve Study
The Learning Curve Associated With Hydrus Microstent Implantation study is an observational research project designed to evaluate the training effectiveness and surgical proficiency of glaucoma fellows in performing minimally invasive Hydrus Microstent implantation. Conducted by the University of Utah in collaboration with Alcon Research, this study aims to determine the mean number of cases required for fellows to achieve and maintain at least an 80% competence score.
Study Population: The study focuses on glaucoma fellows from the Moran Eye Center, Washington University, or Baylor University. These participants are surgical fellows with minimal experience in the procedure, making them ideal subjects for assessing the learning curve.
Intervention: Fellows will undergo surgical video grading, where their surgical cases are recorded and reviewed by a masked grader. The grader will assess each case based on a 12-step competency matrix, scoring each step from 1 (Novice) to 4 (Competent). A total score of 39 out of 48 (80%) is considered competent.
Primary Outcome: The main goal of the study is to determine how many cases fellows need to perform to reach and sustain the 80% competence threshold. This outcome will be measured over an average of 9 months, with study completion expected by July 1, 2025.
Eligibility Criteria: The study is open to current glaucoma fellows at the specified institutions, with no exclusion criteria. This ensures a focused and relevant participant pool.
Significance: Understanding the learning curve for Hydrus Microstent implantation is crucial for improving surgical training programs. By identifying the number of cases needed to achieve competence, this study can help standardize training protocols and enhance patient outcomes.
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