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Completed

NCT Number: NCT06148428

Anxiety-related Fixation Instability During LASIK

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.

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Key information

Conditions

Refractive Errors Anxiety Disorders Eye Diseases Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tiba Eye Center

Asyut, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates undergoing LASIK with
  • Myopia up to 12 diopters
  • Hyperopia up to 6 diopters
  • Astigmatism up to 6 diopters

Exclusion criteria

  • 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.

Treatment and study plan

Laser in Situ Keratomileusis (LASIK)

Procedure

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.

Primary outcomes

  1. The eye-tracking pupil position plot

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: 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.

  2. Subjective evaluation of patient's cooperation by surgeon:

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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