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Vision DisordersNCT05195801

Optic Nerve Diameter and Intraocular Pressure Changes in Patients Undergoing Vitrectomy Under General Anesthesia

An observational study of Vision Disorders and Ocular Surface Disease, run by Akdeniz University at 2 sites in Turkey (Türkiye).

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aimed to measure optic nerve sheath changes in the intraoperative period in patients who underwent vitrectomy surgery and to investigate the intraoperative factors that may affect this. Standard anesthesia protocol will be applied to all patients participating in the study. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Vision Disorders, Ocular Surface Disease
What is being tested?
USG
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jan 2022to 1 Sep 2024
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients undergoing vitrectomy surgery

Who may be able to join

  • Being over 18 years old
  • Taken to elective vitrectomy surgery
  • Asa I - II - III patients
  • GKS 15

Who cannot join

  • Emergency surgeries
  • Patients with a GCS of less than 15 or whose cognitive functions have not been evaluated as clinically sufficient.
  • In cases that cause the termination of the surgical procedure for any reason during the operation
  • Patients followed by neurosurgery and patients with intracranial events

Trial locations and contacts

2 sites in 1 country.

Ilker O Aycan, Prof contact

+905056702335

ilkeraycan@gmail.com

Bora Di̇nc, Assist Prof. contact

+905323865600

drboradinc@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

    Antalya, 07059

    BORA DINC, ASSIST. PROF., +905323865600, drboradinc@gmail.com

    ILKER ONGUC AYCAN, ASSOC. PROF, +905056702335, ilkeraycan@gmail.com

    Recruiting
  • Akdeniz University Hospital

    Antalya, 07070

    Ilker O Aycan, Prof., +905056702335, ilkeraycan@gmail.com

    Bora Di̇nc, Assist. Prof., +905323865600, drboradinc@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Intraoperative Optic Nerve Diameter and Intraocular Pressure Changes in Patients Undergoing Vitrectomy (PPV) Surgery Under General Anesthesia and Their Effects on Vision in the Postoperative Period

This study aimed to measure optic nerve sheath changes in the intraoperative period in patients who underwent vitrectomy surgery and to investigate the intraoperative factors that may affect this.

Standard anesthesia protocol will be applied to all patients participating in the study. Optic nerve sheath diameter measurements of the patients taken to the operating room will be made on the operating table by ultrasonography method. Standard anesthesia induction will be performed following SpO2 and ECG monitoring in routine anesthesia monitoring. Depth of anesthesia will be evaluated with routine hemodynamic data.

Read the detailed description

The optic nerve is part of the central nervous system and is surrounded by the dura, arachnoid, and pia mater; The sheath surrounding the optic nerve is in continuity with the dura mater of the brain and the subarachnoidal space filled with cerebrospinal fluid (CSF), creating a direct connection between the two chambers. (1) The optic nerve sheath continues the dura mater, and the subarachnoid space contains CSF. Thus, any increase in ICP in the subarachnoid space is transferred to the fluid in the optic nerve surrounding it. Because the optic nerve (ONS) can expand, changes in CSF pressure affect the volume of the optic nerve diameter (ONSD) with fluctuations in the anterior retrobulbar compartment, about 3 mm behind the globe. ONSD measurement for CT, MRI, and ultrasound-based intracranial pressure (ICP) detection has been studied previously. Ultrasonography has the potential advantage of being a reproducible, safe, and low-cost tool at the bedside without the risk of radiation and side effects. Sonographic ONSD measurement is made using a linear probe that is carefully placed on the closed upper eyelid without applying pressure to the eye while the patient is in the supine position. (2) Recently, studies have reported that measuring optic nerve sheath diameter (ONSD) using non-invasive imaging technologies provides alternative markers for early rising ICP. (1,2) The retina is the innermost tissue layer of the back of the eye. It consists of multiple layers of cells. The outermost layer is adjacent to the vitreal space and the choroid's innermost layer. Retinal detachment is when the neurosensory retina loses its adhesion to the underlying retinal pigment epithelium (RPE). The outer part of the neurosensory retina is where the photoreceptors are located. The choroid provides oxygen and nutrients for the photoreceptors. There are no retinal blood vessels in the fovea, and the retinal tissue in this area is entirely dependent on the choroid for oxygen requirements. Detachment of the macula can cause permanent damage to the photoreceptors in this location. Vision can be preserved if the macula remains attached and the retina is reattached correctly. (3) There are three categories of retinal detachment: rhegmatogenous, tractional, and exudative. Ruptured retinal detachments are the most common and are caused by fluid passing from the vitreous cavity through a retinal tear or entering the potential space between the sensory retina and the RPE. Tractional detachments occur when the proliferative membranes contract and elevate the retina. Components of rhegmatogenous and tractional etiologies may also lead to retinal detachment. Exudative detachments are caused by fluid buildup under the sensory retina caused by retinal or choroidal diseases. (3) The treatment of torn and tractional retinal detachments is typically surgical. Exudative macular detachments usually have nonsurgical treatment. The prognosis of retinal detachment varies greatly depending on the type of detachment and patient presentation. One of the most important prognostic factors for retinal detachment is whether the macula remains attached. If the macula remains attached, the time until surgery does not change the final visual result. However, the visual prognosis is relatively poor if the macula is detached. (3) Anesthetic agents may affect the ICP during surgery. A dose-dependent decrease in cerebral blood flow, cerebral metabolic rate, and ICP have been reported with propofol anesthesia. Sevoflurane is a cerebral vasodilator that can increase cerebral blood flow, cerebral blood volume, and ICP in a dose-dependent manner. (4)

Anesthetics suppress the activity of the electroencephalogram and reduce the cerebral metabolic rate. However, changes in cerebral metabolic rate and cerebral blood flow are not constant and depend on how anesthesia affects cerebral vascular smooth muscle. Sevoflurane has a dose-dependent effect on vascular smooth muscle relaxation and intrinsic cerebral vasodilator activity through direct inhibition of several pathways. Therefore, cerebral blood flow increases significantly during sevoflurane anesthesia, and ICP may increase as a result. However, propofol slows down EEG activity, reduces adenosine consumption rate, and decreases cerebral metabolic rate. Decreased cerebral metabolic rate decreases cerebral blood flow and cerebral blood perfusion, which decreases ICP. In addition, previous human and animal studies have determined that propofol leads to a progressive decrease in ICP. (4) This study aimed to measure optic nerve sheath changes in the intraoperative period in patients who underwent vitrectomy surgery and to investigate the intraoperative factors that may affect this.

Standard anesthesia protocol will be applied to all patients participating in the study. Optic nerve sheath diameter measurements of the patients taken to the operating room will be made on the operating table by ultrasonography method. Standard anesthesia induction will be performed following SpO2 and ECG monitoring in routine anesthesia monitoring. Depth of anesthesia will be evaluated with routine hemodynamic data.

Being tested
USG
Keywords
vitrectomy, general anaesthesia, optic nerve, intraocular pressure, vision field
Medical subject headings
Vision Disorders

What participants receive

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

  • USGDevice

    Optic Nerve Diameter will be measured in the intraoperative period and postoperative 1st month by ultrasonography method.

Study groups in NCT05195801
Study groupRoleWhat they receive
Group with local anesthesiaThe group that did not apply general anesthesia
Receives: Device: USG
Group with SevofluraneThe Sevoflurane used for maintenance of general anesthesia
Receives: Device: USG
Group with PropofolThe Propofol (IV) used for maintenance of general anesthesia
Receives: Device: USG

What is being measured

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

  1. Optic Nerve Diameter

    This study aims to use the anesthesia methods routinely applied in our hospital's vitrectomy operations. With general anesthesia, intracranial pressure changes, an indication of which is an increase in the diameter of the optic nerve sheath. The expected benefit of this study is to reveal the effects of general anesthesia, patient profile (age, comorbidity, BMI), ventilator parameters on optic nerve sheath diameter in patients undergoing vitrectomy surgery, and to provide optimal intraoperative conditions in the surgery of these patients with parameters that can be corrected and to improve their vision in the postoperative period.

    The optic nerve diameter will be measured at determined time intervals, and changes in diameter will be noted in the study.

    Measured: one month

Secondary outcomes (1)
  1. Vision field

    Changes in the patients' vision field will be measured in the postoperative period.

    Measured: one month

Timeline

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

  1. First posted19 Jan 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195801
Sponsor's protocol ID
Effect of GA on vision in PPV
Status last verified
Jan 2023
First submitted
7 Jan 2022
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen LM, Wang LJ, Hu Y, Jiang XH, Wang YZ, Xing YQ. Ultrasonic measurement of optic nerve sheath diameter: a non-invasive surrogate approach for dynamic, real-time evaluation of intracranial pressure. Br J Ophthalmol. 2019 Apr;103(4):437-441. doi: 10.1136/bjophthalmol-2018-312934. Epub 2018 Oct 25.

    PubMed 30361274
  • Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.

    PubMed 30019201
  • Blair K, Czyz CN. Retinal Detachment. 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551502/

    PubMed 31855346
  • Illarionov AM. [The blood coagulation and its fibrinolytic activity in patients who have sustained an apoplectic stroke]. Sov Med. 1966 Feb;29(2):76-7. No abstract available. Russian.

    PubMed 6011519

Questions about this trial

What is this clinical trial studying?

An observational study of Vision Disorders and Ocular Surface Disease, run by Akdeniz University at 2 sites in Turkey (Türkiye).

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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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 Ilker O Aycan, Prof (+905056702335, ilkeraycan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optic Nerve Diameter (time frame: one month). 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 NCT05195801, which also lists 4 linked publications.

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 13 Jan 2023.

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Clinical Trial NCT05195801 | AzTrials