Refractive ErrorsNCT06148428
Anxiety-related Fixation Instability During LASIK
An observational study of Refractive Errors, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Laser in situ keratomileusis (LASIK)
- Type of treatment
- Surgery or procedure
- How many people
- 2,435 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2018to 15 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Candidates undergoing LASIK with
- Myopia up to 12 diopters
- Hyperopia up to 6 diopters
- Astigmatism up to 6 diopters
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety-related Fixation Instability During Laser in Situ Keratomileusis (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.
Read the 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
- Being tested
- Laser in situ keratomileusis (LASIK)
- Keywords
- Laser in Situ Keratomileusis, Anxiety, Eye-tracker, Fixation instability
- Medical subject headings
- Refractive Errors, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser in situ keratomileusis (LASIK)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Procedure: Laser in situ keratomileusis (LASIK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following surgery
Secondary outcomes (2)
Heart rate
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.
Measured: During and at the end of surgery.
Subjective evaluation of patient's cooperation by surgeon:
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).
Measured: Immediately following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start15 Aug 2018
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdel-Radi, Assiut University
- Investigators
- Mahmoud Abdel-Radi, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148428
- Sponsor's protocol ID
- ARFILASIK
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29184388
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety-related Fixation Instability During Laser in Situ Keratomileusis (LASIK)
- ClinicalTrials.gov ID
- NCT06148428
- Acronym / sponsor ID
- ARFILASIK
- Conditions
- Refractive Errors
- Keywords
- Laser in Situ Keratomileusis, Anxiety, Eye-tracker, Fixation instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,435 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Procedure: Laser in situ keratomileusis (LASIK)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). |
| Borderline anxiety group | – | Procedure: Laser in situ keratomileusis (LASIK)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). |
| Anxious group | – | Procedure: Laser in situ keratomileusis (LASIK)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Candidates undergoing LASIK with
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Anxious group, Borderline anxiety group, Normal group |
Primary outcome
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.
2 secondary outcomes
Heart rate
Time frame: During and at the end of surgery.
Subjective evaluation of patient's cooperation by surgeon:
Time frame: Immediately following surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 29184388Ramirez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Abdel-Radi, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eye-tracking pupil position plot (time frame: Immediately following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.