Anxiety-related Fixation Instability During LASIK

NCT ID: NCT06148428

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2023-07-15

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.

Conditions

Refractive Errors

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Laser in situ keratomileusis (LASIK)

Intervention Type: 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.

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).

Laser in situ keratomileusis (LASIK)

Intervention Type: 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

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).

Laser in situ keratomileusis (LASIK)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdel-Radi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Abdel-Radi, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Tiba Eye Center

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29184388 (View on PubMed)

Other Identifiers

ARFILASIK

Identifier Type: -

Identifier Source: org_study_id