NCT06148428|Completed
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Sponsor study identifier
observational
2,435
1 country
1
Study Start
August 15, 2018
Actual (reported)Primary Completion
July 15, 2023
Actual (reported)Study Completion
July 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 15, 2018
Actual (reported)July 15, 2023
Actual (reported)July 15, 2023
Actual (reported)November 19, 2023
Actual (reported)November 28, 2023
Actual (reported)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
Heart rate
During and at the end of surgery.
Subjective evaluation of patient's cooperation by surgeon:
Immediately following surgery.
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).
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).
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).
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.
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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.
Tiba Eye Center
Asyut, 71516, Egypt
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.
Mahmoud Abdel-Radi, MD
Assiut University
2,435 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2023
First Posted
November 28, 2023
Study Start
August 15, 2018
Actual (reported)Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
Contact the study team to confirm eligibility.
Primary Completion
July 15, 2023
Actual (reported)Study Completion
July 15, 2023
Actual (reported)Last Updated
November 30, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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