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).
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
Turkey (Türkiye)2 sites, 2 recruiting
- 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
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.
- Conditions
- Vision Disorders, Ocular Surface Disease
- 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 group | Role | What they receive |
|---|---|---|
| Group with local anesthesia | The group that did not apply general anesthesia Receives: Device: USG | |
| Group with Sevoflurane | The Sevoflurane used for maintenance of general anesthesia Receives: Device: USG | |
| Group with Propofol | The 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.
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)
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.
- First posted19 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Onguc Aycan, Akdeniz University
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 30361274Robba 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 30019201Blair 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 31855346Illarionov 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05195801
- Acronym / sponsor ID
- Effect of GA on vision in PPV
- Conditions
- Vision Disorders, Ocular Surface Disease
- Keywords
- vitrectomy, general anaesthesia, optic nerve, intraocular pressure, vision field
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 19 Jan 2022 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group with local anesthesia | – | Device: USGThe group that did not apply general anesthesia |
| Group with Sevoflurane | – | Device: USGThe Sevoflurane used for maintenance of general anesthesia |
| Group with Propofol | – | Device: USGThe Propofol (IV) used for maintenance of general anesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing vitrectomy surgery
Key inclusion criteria (4 listed)
- Being over 18 years old
- Taken to elective vitrectomy surgery
- Asa I - II - III patients
- GKS 15
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| USGOptic Nerve Diameter will be measured in the intraoperative period and postoperative 1st month by ultrasonography method. | Device | Group with Propofol, Group with Sevoflurane, Group with local anesthesia |
Primary outcome
Optic Nerve Diameter
Time frame: one month
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.
1 secondary outcome
Vision field
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Background: PubMed 30361274Chen 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.
- Background: PubMed 30019201Robba 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.
- Background: PubMed 31855346Blair 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/
- Background: PubMed 6011519Illarionov 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.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
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.