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CataractNCT03749759

Perioperative Stress and Pain Perception of Second Eye Cataract Surgery

A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Purpose of this study is to find a correlation between agitation (stress) indicating parameters and the pain perception during second eye cataract surgery, compared to first eye cataract surgery. Read more about this study

Who is it for?
Ages 21 to 105 years
Conditions the study is for
Cataract
What is being tested?
Cataract surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteAustria
Study dates
1 Jan 2017to 1 Jan 2021
Phase
Interventional
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 21 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21 and older
  • written informed consent prior to surgery
  • bilateral age-related cataract

Who cannot join

  • deafness
  • allergy to topical anesthetic agents
  • severe anxiety and involuntary eye and head movements
  • conditions likely to require surgical therapy other than routine phacoemulsification (eg: traumatic and complicated cataracts)
  • in case of pregnancy (pregnancy test will be taken in women of reproductive age)

Trial locations and contacts

1 site in 1 country.

John Falasinnu, MD contact

01 91021-57559

office@viros.at

Katharina Kefer contact

01 91021-57564

office@viros.at

Austria1 site, 1 recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS)

    Vienna, 1140

    John Falasinnu, MD, 01 910 21-57559, office@viros.at

    Katharina Kefer, 01 910 21-57564, office@viros.at

    Recruiting

Other trials in Austria

About this study

Official title: Pain Perception and Discomfort of Second Eye Cataract Surgery in Comparison With the First Eye in Correlation With Perioperative Stress

Purpose of this study is to find a correlation between agitation (stress) indicating parameters and the pain perception during second eye cataract surgery, compared to first eye cataract surgery.

Read the detailed description

A cataract, which is the clouding of the eye's natural lens as a result of aging or injury, is the leading cause of preventable blindness worldwide. As one of the of the most common surgical procedures, cataract surgery is performed almost 22 million times worldwide each year. The World Health Organisation estimates that by 2020 more than 32 million cataract surgeries will take place globally per annum.

Phacoemulsification cataract surgery in topical anaesthesia has become the anaesthetic method of choice since first described by Fichman in 1992. Although this procedure has proven to be relatively painless, safe and effective, patients often report increased pain or discomfort during surgery of the second eye. Several studies were performed to find out if there was any proof to that common finding and some tried to find a correlation to fear and anxiety using standardized questionnaires.

In one study of 65 patients there was a subtle increase in pain in the second surgery relative to the first which appeared to be associated with decreased preoperative anxiety. Another study found that previous cataract extraction correlated negatively, but weakly with preoperative anxiety.

A study of 70 patients having first cataract extraction found no difference in mean pain scores, fear and anxiety when compared with a second, independent population of 57 patients having second cataract extraction. A similar outcome was found in 2 other studies where there was no difference in perceived pain between the first and second cataract surgery.

Summarized, the results in the related literature are controversial concerning the assessment of pain, fear and anxiety during cataract surgery performed in the second eye.

Emotional stress and anxiety in surgical patients lead to sympathetic stimulation with tachycardia, hypertension and possible cardiac ischaemia which are haemodynamic stress responses, triggered by endocrine regulatory mechanisms and the autonomic nervous system with increased cortisol, adrenaline and noradrenaline blood levels. Furthermore palmar and plantar sweat glands activity decreases skin resistance which is shown as a surge in electric skin conductance in bio- feedback measurements.

For obtaining and processing the information about these physiological reactions a system with the ability to measure and record various bio-signals is needed. These kind of systems are used for biofeedback. Galvanic Skin response Sensors measure the above mentioned electrical conductance of the skin. It is used as an indication of psychological and physiological excitation and thus represents an indicator for the individual's stress response.

Electromyograph (EMG) uses surface electrodes to measure the electrical activity of the skeletal muscles when they are relaxed and contracted by detecting the combined electrical potential generated by the muscle cells. The mean value of the rectified EMG signal of the upper trapezius muscle increases during stressful conditions and decreases again during relaxation periods.

Electrocardiogram (ECG) electrodes are used to measure the heart function and further calculate the heart rate variability (HRV). HRV is defined as the beat-to-beat changes, the interbeat interval, which is the time between two successive R waves. HRV is considered as a measure of the interaction between sympathetic and parasympathetic influence on heart rate. The activation of the sympathetic branch of the autonomic nervous system increases heart rate, while the activation of the parasympathetic branch, primarily mediated by the vagus nerve, slows it. These physiological signals provide a reliable measurement of agitation (stress).

Conditions
Cataract
Being tested
Cataract surgery
Keywords
Cataract, Cataract surgery, Biofeedback
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgeryProcedure or surgery

    A biofeedback measurement will be carried out during cataract surgery of both eyes

Study groups in NCT03749759
Study groupRoleWhat they receive
Biofeedback measurementExperimentalA Biofeedback measurement will be done during cataract surgery of both eyes
Receives: Procedure: Cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative agitation (stress) measurement

    Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.

    Measured: 12 months

Secondary outcomes (1)
  1. Assessment of pain perception

    Pain perception of the patients will be assessed during the two cataract surgeries using an visual analogue scale, where 10 means highest pain and 1 is lowest pain.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start1 Jan 2017
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03749759
Sponsor's protocol ID
Neuromaster
Status last verified
Feb 2019
First submitted
20 Nov 2018
Last updated
27 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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 Austria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact John Falasinnu, MD (01 91021-57559, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative agitation (stress) measurement (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Feb 2019.

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