- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580573
AI in Assessing Aesthetic Outcomes in Rhinoplasty
Use of Artificial Intelligence in Assessment of Aesthetic Outcomes in Rhinoplasty
This study aims to thoroughly assess the predictive accuracy of artificial intelligence-based nasal outcome simulations by comparing AI-generated preoperative predictions with objective postoperative nasal morphology using digital image analysis.
To assess accuracy of AI-image measurement compared with imageJ software
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rhinoplasty is a surgical procedure that aims to enhance nasal aesthetics while preserving structural integrity and function. It focuses on minimizing tissue disruption through techniques such as cartilage reshaping, selective preservation, and grafting to maintain support. The primary goal is to achieve natural-looking outcomes while ensuring adequate nasal breathing and reducing postoperative complications.
Despite its widespread application, rhinoplasty remains one of the most complex procedures in aesthetic surgery due to the variability in individual anatomy and patient expectations. Conventional standardized approaches often fail to fully address these differences. Subjective assessment tools, including patient-reported outcome measures, provide insight into satisfaction with aesthetic and functional results; however, they are limited by lack of objectivity. Zojaji et al. demonstrated no strong correlation between objective facial proportion changes and Rhinoplasty Outcome Evaluation (ROE) scores, emphasizing the discrepancy between perceived and measured outcomes.
Recent advances in artificial intelligence (AI) have introduced innovative solutions to these challenges. AI-driven simulations enable the generation of realistic preoperative predictions, thereby improving surgical planning and patient communication.Furthermore, AI-based image analysis applications allow for precise and automated measurement of nasal parameters, including linear distances, angles, proportions, and symmetry, using standardized digital photographs. These tools provide objective and reproducible data, reduce observer variability, and enhance the accuracy of postoperative outcome assessment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients age> 18 years old.
- patients schedule for rhinoplasty surgery
Exclusion Criteria:
- Pervious nasal trauma that affect anatomical land mark
- pervious nasal surgery (rhinoplasty or others)
- patients with psychological disorders.
- patients with any coagulopathy disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: AI-Based Assessment
|
using AI-driven simulations which enable the generation of realistic preoperative predictions, thereby improving surgical planning and patient communication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Agreement between ImageJ and AI application measurements
Time Frame: basline
|
basline
|
|
Evaluate the accuracy of AI-based simulation in predicting postoperative aesthetic outcomes following structural rhinoplasty by comparing AI-generated preoperative simulations with actual postoperative nasal morphology using objective digital image a
Time Frame: basline
|
basline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Omer G, Girolamo S, Hamatofiq B, Tofiq S, Mohammed MA, Abdulkarim D, Mohammed S, Gubari M, Habibullah I, Mustafa A, Fatah M, Ahmed S, Kakamad F. Functional, Cosmetic, and Psychological Outcomes after Rhinoplasty. Plast Reconstr Surg Glob Open. 2024 Aug 16;12(8):e6057. doi: 10.1097/GOX.0000000000006057. eCollection 2024 Aug.
- Zhao R, Chen K, Tang Y. Effects of Functional Rhinoplasty on Nasal Obstruction: A Meta-Analysis. Aesthetic Plast Surg. 2022 Apr;46(2):873-885. doi: 10.1007/s00266-021-02741-2. Epub 2022 Jan 31.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UAIAAOR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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