The Effect of Postural Changes on Intraocular Pressure in... | NCT01992510

Studies
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes

NCT01992510

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Dec 23, 2013Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Silicone Tamponade

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Not provided

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2013

Last Update Posted Date

Dec 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Ho Park, Department of Ophthalmology, School of Medicine, Kyungpook National University, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

The study was conducted to investigate how postural changes including sitting, supine, and LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes and the fellow eyes in each body position.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
silicone oil fiiled eye		those with a condition
fellow eye		the contralateral eye in the same patient

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean IOP(intraocular pressure) at each time point during the change in body position		100 minutes

Secondary Outcomes

Measure	Description	Time Frame
IOP(intraocular pressure)differences between the SO(silicone oil)-filled eye and the fellow eyes at each time point during the change in body position		100 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who had a 23-gauge pars plana vitrectomy
must be done with SO(silicone oil,5,000 centistrokes) endotamponade using the Accurus system (Alcon Laboratories, Inc, Hünenberg,Switzerland)

Exclusion Criteria:

previous history or presence of glaucoma or uveitis
IOP of ≥24 mmHg
use of any antiglaucoma agents
narrow angles
corneal abnormality or diseases that could affect IOP
refractive error exceeding a spherical equivalent of 6 diopters.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

33 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

silicone tamponade patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, School of Medicine, Kyungpook National University		Daegu	Jung-gu	700-721	South Korea