Clinical trial NCT06148428: Anxiety-related Fixation Instability During LASIK
Official title: Anxiety-related Fixation Instability During Laser in Situ Keratomileusis (LASIK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Keywords: Laser in Situ Keratomileusis
Anxiety
Eye-tracker
Fixation instability
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 2435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This cohort study was conducted at 2 refractive surgery centers in Assiut city, Egypt (Private practice) and included patients who were candidates for LASIK eye surgery for correction of their refractive errors including myopia, hyperopia and astigmatism.

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.

Eligibility criteria: Inclusion Criteria:

* Candidates undergoing LASIK with

  1. Myopia up to 12 diopters
  2. Hyperopia up to 6 diopters
  3. Astigmatism up to 6 diopters

Exclusion Criteria:

1. Previous corneal surgery,
2. Pregnant or lactating females,
3. Concomitant ocular or systemic disease that contraindicated LASIK,
4. Patients with communication barriers, hypochondria, previous stressful surgical experiences, taking psychotropic drugs, or having a history of any clinically relevant psychiatric or cardiovascular disease.

Primary outcomes:
measure: The eye-tracking pupil position plot
timeFrame: Immediately following surgery
Secondary outcomes:
measure: Heart rate
timeFrame: During and at the end of surgery.
measure: Subjective evaluation of patient's cooperation by surgeon:
timeFrame: Immediately following surgery.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Tiba Eye Center
Study officials:
affiliation: Assiut University
name: Mahmoud Abdel-Radi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez DA, Brodie FL, Rose-Nussbaumer J, Ramanathan S. Anxiety in patients undergoing cataract surgery: a pre- and postoperative comparison. Clin Ophthalmol. 2017 Nov 10;11:1979-1986. doi: 10.2147/OPTH.S146135. eCollection 2017.