Intraocular Pressure ChangesENDO-IOPNCT07190508
Intraocular Pressure Changes During EGD
An observational study of Intraocular Pressure Changes and Upper Gastrointestinal Endoscopy, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates short-term changes in intraocular pressure (IOP) during elective esophagogastroduodenoscopy (EGD) performed under routine sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure Changes, Upper Gastrointestinal Endoscopy
- Type of treatment
- Injection or infusion
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients scheduled for elective esophagogastroduodenoscopy (EGD) under routine sedation at the endoscopy unit of Elazig Fethi Sekin City Hospital were screened for eligibility. Patients meeting the predefined inclusion criteria and without any exclusion criteria were enrolled in this prospective observational cohort.
Who may be able to join
- Age ≥18 years
- Scheduled for elective esophagogastroduodenoscopy (EGD)
- Acceptance of the procedure under sedation
- Ability to cooperate with intraocular pressure (IOP) and central corneal thickness (CCT) measurements
Who cannot join
- Diagnosis of glaucoma or ocular hypertension
- Corneal diseases that could affect intraocular pressure or central corneal thickness measurements
- Ocular infection
- Severe dry eye disease
- Hemodynamic instability
- Heart failure
Show all 11Show fewer
- Renal failure
- Cirrhosis or other clinical conditions contraindicating fluid loading
- Use of topical ocular medications, including antiglaucoma drugs or topical steroids
- History of ocular surgery
- History of refractive laser procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official title: Sedation-related Intraocular Pressure Changes During Esophagogastroduodenoscopy: a Prospective Observational Study
This prospective observational study evaluates short-term changes in intraocular pressure (IOP) during elective esophagogastroduodenoscopy (EGD) performed under routine sedation. IOP is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: baseline in the sitting position (T0), after routine administration of 500 mL isotonic intravenous fluid in the sitting position (T1), after sedation in the left lateral decubitus position before endoscopy (T2), and when the endoscope reaches the second portion of the duodenum (T3). The primary outcome is the within-subject change in IOP across these procedural stages. Secondary analyses include differences between the dependent and non-dependent eyes in the left lateral decubitus position and exploratory assessment of factors associated with the change in left-eye IOP from baseline to duodenal passage. No study-specific intervention or treatment allocation is performed; all clinical procedures follow routine institutional practice.
Read the detailed description
This single-center, prospective observational cohort study was conducted at Elazig Fethi Sekin City Hospital, Türkiye, in adults (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. Consecutive patients were screened for eligibility. Exclusion criteria included glaucoma or ocular hypertension, corneal disease affecting intraocular pressure (IOP) or corneal thickness measurements, ocular infection, severe dry eye disease, hemodynamic instability, heart failure, renal failure, cirrhosis or other conditions contraindicating fluid loading, use of topical ocular medications, and previous ocular surgery or refractive laser procedures.
After venous access was established, baseline central corneal thickness and bilateral IOP were measured. As part of routine institutional practice, patients received 500 mL of 0.9% NaCl intravenously over approximately 10-15 minutes before sedation. This fluid administration was not assigned as a study-specific experimental intervention. Sedation was administered as part of routine clinical care using midazolam 0.02 mg/kg IV and propofol 0.5 mg/kg IV, with additional 10-20 mg propofol boluses as clinically required. Spontaneous breathing was maintained, supplemental oxygen was administered by nasal cannula, and noninvasive blood pressure, cardiac rhythm, and peripheral oxygen saturation were continuously monitored.
Intraocular pressure was measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before endoscopy; and T3, when the endoscope reached the second portion of the duodenum while the patient remained in the left lateral decubitus position.
The primary outcome was the within-subject change in IOP across T0-T3. Secondary analyses included paired comparison of the dependent and non-dependent eyes at T2 and T3 and exploratory multivariable analysis of factors associated with the change in left-eye IOP from baseline to duodenal passage (T3-T0). Repeated-measures analyses were used to evaluate changes over time. No study-specific intervention or treatment allocation was performed; all clinical procedures were conducted according to routine institutional practice. Forty-seven participants with complete IOP measurements at all predefined time points were included in the final analysis.
- Being tested
- No Intervention (Observational)
- Keywords
- Intraocular Pressure, Endoscopy, Gastrointestinal, Sedation, Propofol, Midazolam, Fentanyl, Duodenum, Tonometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention (Observational)Other
Participants undergo routine diagnostic upper gastrointestinal endoscopy with standard institutional care. No additional intervention is applied beyond usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Upper GI Endoscopy Patients | Adult patients (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. As part of routine institutional practice, patients receive 500 mL of 0.9% NaCl intravenously before sedation. Intraocular pressure is measured bilaterally at four predefined procedural time points: baseline in the sitting position (T0), after fluid administration in the sitting position (T1), after sedation in the left lateral decubitus position before endoscopy (T2), and when the endoscope reaches the second portion of the duodenum (T3). Receives: Other: No Intervention (Observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
Intraocular pressure (IOP) is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic intravenous fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before the start of endoscopy; and T3, when the endoscope reaches the second portion of the duodenum while the patient remains in the left lateral decubitus position. The primary outcome is the within-subject change in IOP across T0-T3.
Measured: During the EGD procedure, from baseline before fluid administration to advancement of the endoscope into the second portion of the duodenum.
Secondary outcomes (4)
Change in Systolic Blood Pressure (SBP)
Systolic blood pressure is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Measured: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Change in Diastolic Blood Pressure (DBP)
Diastolic blood pressure is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Measured: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Change in Heart Rate (HR)
Heart rate is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Measured: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Difference in Intraocular Pressure Between the Dependent and Non-Dependent Eyes
Intraocular pressure is compared between the dependent left eye and the non-dependent right eye while patients are in the left lateral decubitus position. Paired inter-eye differences are evaluated at T2, after sedation and before the start of endoscopy, and at T3, when the endoscope reaches the second portion of the duodenum.
Measured: During the EGD procedure at T2 and T3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraocular Pressure ChangesStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevim Şenol Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sevim Şenol Karataş, MD, Principal investigator, Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190508
- Sponsor's protocol ID
- EFSH-ANES-2025-09-IOP
- Acronym
- ENDO-IOP
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is a single-center observational project with a limited sample size and no data repository plan. Only aggregated results will be reported in publications.
Publications
Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.
PubMed 18452762Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
PubMed 21072716
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation-related Intraocular Pressure Changes During Esophagogastroduodenoscopy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07190508
- Acronym / sponsor ID
- ENDO-IOP / EFSH-ANES-2025-09-IOP
- Keywords
- Intraocular Pressure, Endoscopy, Gastrointestinal, Sedation, Propofol, Midazolam, Fentanyl, Duodenum, Tonometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sevim Şenol KarataşUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 24 Sep 2025 (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 prospective observational study evaluates short-term changes in intraocular pressure (IOP) during elective esophagogastroduodenoscopy (EGD) performed under routine sedation. IOP is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: baseline in the sitting position (T0), after routine administration of 500 mL isotonic intravenous fluid in the sitting position (T1), after sedation in the left lateral decubitus position before endoscopy (T2), and when the endoscope reaches the second portion of the duodenum (T3). The primary outcome is the within-subject change in IOP across these procedural stages. Secondary analyses include differences between the dependent and non-dependent eyes in the left lateral decubitus position and exploratory assessment of factors associated with the change in left-eye IOP from baseline to duodenal passage. No study-specific intervention or treatment allocation is performed; all clinical procedures follow routine institutional practice.
Detailed description
This single-center, prospective observational cohort study was conducted at Elazig Fethi Sekin City Hospital, Türkiye, in adults (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. Consecutive patients were screened for eligibility. Exclusion criteria included glaucoma or ocular hypertension, corneal disease affecting intraocular pressure (IOP) or corneal thickness measurements, ocular infection, severe dry eye disease, hemodynamic instability, heart failure, renal failure, cirrhosis or other conditions contraindicating fluid loading, use of topical ocular medications, and previous ocular surgery or refractive laser procedures.
After venous access was established, baseline central corneal thickness and bilateral IOP were measured. As part of routine institutional practice, patients received 500 mL of 0.9% NaCl intravenously over approximately 10-15 minutes before sedation. This fluid administration was not assigned as a study-specific experimental intervention. Sedation was administered as part of routine clinical care using midazolam 0.02 mg/kg IV and propofol 0.5 mg/kg IV, with additional 10-20 mg propofol boluses as clinically required. Spontaneous breathing was maintained, supplemental oxygen was administered by nasal cannula, and noninvasive blood pressure, cardiac rhythm, and peripheral oxygen saturation were continuously monitored.
Intraocular pressure was measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before endoscopy; and T3, when the endoscope reached the second portion of the duodenum while the patient remained in the left lateral decubitus position.
The primary outcome was the within-subject change in IOP across T0-T3. Secondary analyses included paired comparison of the dependent and non-dependent eyes at T2 and T3 and exploratory multivariable analysis of factors associated with the change in left-eye IOP from baseline to duodenal passage (T3-T0). Repeated-measures analyses were used to evaluate changes over time. No study-specific intervention or treatment allocation was performed; all clinical procedures were conducted according to routine institutional practice. Forty-seven participants with complete IOP measurements at all predefined time points were included in the final analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper GI Endoscopy Patients | – | Other: No Intervention (Observational)Adult patients (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. As part of routine institutional practice, patients receive 500 mL of 0.9% NaCl intravenously before sedation. Intraocular pressure is measured bilaterally at four predefined procedural time points: baseline in the sitting position (T0), after fluid administration in the sitting position (T1), after sedation in the left lateral decubitus position before endoscopy (T2), and when the endoscope reaches the second portion of the duodenum (T3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients scheduled for elective esophagogastroduodenoscopy (EGD) under routine sedation at the endoscopy unit of Elazig Fethi Sekin City Hospital were screened for eligibility. Patients meeting the predefined inclusion criteria and without any exclusion criteria were enrolled in this prospective observational cohort.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Scheduled for elective esophagogastroduodenoscopy (EGD)
- Acceptance of the procedure under sedation
- Ability to cooperate with intraocular pressure (IOP) and central corneal thickness (CCT) measurements
Key exclusion criteria (11 listed)
- Diagnosis of glaucoma or ocular hypertension
- Corneal diseases that could affect intraocular pressure or central corneal thickness measurements
- Ocular infection
- Severe dry eye disease
- Hemodynamic instability
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 |
|---|---|---|
| No Intervention (Observational)Participants undergo routine diagnostic upper gastrointestinal endoscopy with standard institutional care. No additional intervention is applied beyond usual clinical practice. | Other | Upper GI Endoscopy Patients |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: During the EGD procedure, from baseline before fluid administration to advancement of the endoscope into the second portion of the duodenum.
Intraocular pressure (IOP) is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic intravenous fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before the start of endoscopy; and T3, when the endoscope reaches the second portion of the duodenum while the patient remains in the left lateral decubitus position. The primary outcome is the within-subject change in IOP across T0-T3.
4 secondary outcomes
Change in Systolic Blood Pressure (SBP)
Time frame: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Change in Diastolic Blood Pressure (DBP)
Time frame: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Change in Heart Rate (HR)
Time frame: During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).
Difference in Intraocular Pressure Between the Dependent and Non-Dependent Eyes
Time frame: During the EGD procedure at T2 and T3.
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 9 Sep 2026.
- Background: PubMed 18452762Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.
- Background: PubMed 21072716Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
- Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and ReanimationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is a single-center observational project with a limited sample size and no data repository plan. Only aggregated results will be reported in publications.
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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.
Sevim Şenol Karataş, MD principal investigator
Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
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 Intraocular Pressure Changes and Upper Gastrointestinal Endoscopy, run by Sevim Şenol Karataş at 1 site 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 11 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 9 Sep 2026. 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 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?
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?
Change in Intraocular Pressure (IOP) (time frame: During the EGD procedure, from baseline before fluid administration to advancement of the endoscope into the second portion of the duodenum.). 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 NCT07190508, which also lists 2 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 9 Sep 2026.