Ignite Creation Date:
2024-05-06 @ 8:44 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02818530
Status:
TERMINATED
Last Update Posted:
2018-05-14
First Post:
2016-06-18
Brief Title:
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound
Sponsor:
Tata Memorial Centre
Organization:
Tata Memorial Centre
Study Overview
Official Title:
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intra ocular pressure IOP may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values Major determinants of IOP are aqueous humor flow choroidal blood volume central venous pressure and extra ocular muscle tone
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth ACD with the intraocular pressure measured by tonometer They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP who are unable to open their eyes
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth ACD with the intraocular pressure measured by tonometer They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP who are unable to open their eyes
Detailed Description:
Intra ocular pressure IOP may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values Major determinants of IOP are aqueous humor flow choroidal blood volume central venous pressure and extra ocular muscle tone During the robotic surgery there are two theories explaining the increase of IOP first gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase IOP Second intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in IOP increase One study reported that low end tidal carbon dioxide was a significant predictor of the IOP increase Continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased IOP
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth ACD with the intraocular pressure measured by tonometer They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP who are unable to open their eyes It can also be used for serial examination and follow-up of treatment success They also mentioned that it is necessary to conduct a prospective study with a larger sample size to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound In addition it is essential to determine the cut off normal ACD for evaluation of IOP
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth ACD with the intraocular pressure measured by tonometer They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP who are unable to open their eyes It can also be used for serial examination and follow-up of treatment success They also mentioned that it is necessary to conduct a prospective study with a larger sample size to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound In addition it is essential to determine the cut off normal ACD for evaluation of IOP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None