Anxiety-related Fixation Instability During LASIK

NCT06148428 | Completed

• 1 other identifier: ARFILASIK
• Study Type: observational
• Target: 2,435
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors

Keywords

Laser in Situ Keratomileusis; Anxiety; Eye-tracker; Fixation instability

Outcome Measures

Primary Outcomes (1)

• The eye-tracking pupil position plot

  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.

  Immediately following surgery

Secondary Outcomes (2)

• Heart rate

  During and at the end of surgery.

• Subjective evaluation of patient's cooperation by surgeon:

  Immediately following surgery.

Study Arms (3)

Normal group

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).

Procedure: Laser in situ keratomileusis (LASIK)

Borderline anxiety group

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).

Procedure: Laser in situ keratomileusis (LASIK)

Anxious group

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).

Procedure: Laser in situ keratomileusis (LASIK)

Interventions

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.

Anxious group; Borderline anxiety group; Normal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Tiba Eye Center

Asyut, 71516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29184388 BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Anxiety Disorders

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Eye Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Mahmoud Abdel-Radi, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 28, 2023
• Study Start: August 15, 2018
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)