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Anxiety-related Fixation Instability During LASIK

NCT06148428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2435

Last updated 2023-11-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mahmoud Abdel-Radi, MD · Assiut University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2023-07-15
Completion
2023-07-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06148428 on ClinicalTrials.gov