Anxiety-related Fixation Instability During LASIK
- Conditions
- Refractive Errors
- Interventions
- Procedure: Laser in situ keratomileusis (LASIK)
- Registration Number
- NCT06148428
- Lead Sponsor
- Assiut University
- Brief Summary
Anxiety is common among patients undergoing eye surgery, which is typically performed under topical anesthesia while the patient is awake. This can be an unsettling experience for patients, who may worry about being able to keep their eyes still during surgery, cooperate with the surgical team, and remain immobile in an unfamiliar environment. Patients may also experience anxiety due to concerns about surgical pain, possible complications, and the uncertainty of the outcome of the surgery.
In this study, the investigators aimed to investigate the correlation between the severity of anxiety symptoms during LASIK, and fixation instability during photo-ablation as plotted by the eye tracker.
- Detailed Description
Patient cooperation during LASIK is essential for the surgeon's comfort and predictable results. Fixation instability, which is the inability of the patient to keep their eye still during surgery, is a common problem during LASIK surgery and may lead to unexpected outcomes.
Eye movements occur continually during the excimer ablation. These eye movements can have a large amplitude, a frequency of over 100 Hz, and a corneal speed of around 150 mm/s. With the advancement of scanning-spot excimer lasers, much work has focused on increasing the efficacy of the photo-ablation and smoothness of the ablated surface, especially with respect to the position of the patient's eye by developing state-of-the-art eye trackers to help maintain alignment during photoablation, which can improve refractive outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2435
-
Candidates undergoing LASIK with
- Myopia up to 12 diopters
- Hyperopia up to 6 diopters
- Astigmatism up to 6 diopters
- Previous corneal surgery,
- Pregnant or lactating females,
- Concomitant ocular or systemic disease that contraindicated LASIK,
- Patients with communication barriers, hypochondria, previous stressful surgical experiences, taking psychotropic drugs, or having a history of any clinically relevant psychiatric or cardiovascular disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anxious group Laser in situ keratomileusis (LASIK) Based on the Hospital Anxiety and Depression scale anxiety sub-score (HADS anxiety sub-score, the seven-item anxiety sub-score for scaling a patient's anxiety levels before LASIK) Patients who had a sub-score of 11-21 is abnormal and denotes a definite anxiety scale (case). Borderline anxiety group Laser in situ keratomileusis (LASIK) Based on the Hospital Anxiety and Depression scale anxiety sub-score (HADS anxiety sub-score, the seven-item anxiety sub-score for scaling a patient's anxiety levels before LASIK) Patients who had a sub-score of 8-10 denotes doubtful anxiety scale (borderline). Normal group Laser in situ keratomileusis (LASIK) Based on the Hospital Anxiety and Depression scale anxiety sub-score (HADS anxiety sub-score, the seven-item anxiety sub-score for scaling a patient's anxiety levels before LASIK) Patients who had a sub-score of ≤7 denotes no anxiety scale (normal).
- Primary Outcome Measures
Name Time Method The eye-tracking pupil position plot Immediately following surgery This is a scheme that allows the system to capture the image, process it, and then verify eye position with the next image before releasing the pulse. After treatment, the system releases a summarized treatment report including a plot that depicts various pupil center positions within 3.0 mm off-center (on x and y axes) relative to the eye tracking cameras during ablation.
- Secondary Outcome Measures
Name Time Method Heart rate During and at the end of surgery. Upon entering the operating room, patients were attached to a pulse oximeter, and an operating room nurse recorded the heart rate (HR) at the start of the operation, during flap creation, during ablation, and at the end of surgery.
Subjective evaluation of patient's cooperation by surgeon: Immediately following surgery. The patient's cooperation during the surgery period was graded by the surgeon choosing a number on a scale from one to ten considering 1 as totally cooperative (calm and steady fixing) and 10 as totally uncooperative (marked eye and head movement and/or lid squeezing).
Trial Locations
- Locations (1)
Tiba Eye Center
🇪🇬Assiut, Egypt