NCT06148428

Anxiety-related Fixation Instability During LASIK

Anxiety-related Fixation Instability During Laser in Situ Keratomileusis (LASIK)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,435 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
PROCEDURE	Laser in situ keratomileusis (LASIK)	Patients were planned to undergo laser in situ keratomileusis. Local anesthesia was achieved by preservative-free oxybuprocaine hydrochloride 0.4% drops (a commonly used topical anesthetic due to its effectiveness in alleviating pain and ocular surface discomfort during the procedure). During surgery, the lights of the operating room were dimmed as much as possible and the surgeons spoke to the patients in a calm voice and explained what was happening. They also reassured the patients that the surgery was going as planned and would be over soon. For patients undergoing (Microkeratome) MK-LASIK, a Moria 2 Microkeratome (Moria SA, Antony, France) was used to create the flap. For patients undergoing Femtosecond LASIK (FS-LASIK), the Allegretto Wave Light FS-200 femtosecond Laser (Alcon labs, Fort Worth, TX, USA) was used for flap creation. Laser ablation was performed using WaveLight EX500 Excimer Laser (Alcon labs, Fort Worth, TX, USA) with a planned post-operative emmetropia.

Timeline

• Start date: 2018-08-15
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2023-11-28
• Last updated: 2023-11-30

Locations

1 site across 1 country: Egypt