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

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ClinicalTrials.gov Identifier: NCT01992510
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University Hospital

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.

Condition or disease
Silicone Tamponade

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : January 2012
Actual Primary Completion Date : January 2013

Group/Cohort
silicone oil fiiled eye
those with a condition
fellow eye
the contralateral eye in the same patient



Primary Outcome Measures :
  1. Mean IOP(intraocular pressure) at each time point during the change in body position [ Time Frame: 100 minutes ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 100 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   33 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
silicone tamponade patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992510


Locations
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Korea, Republic of
Department of Ophthalmology, School of Medicine, Kyungpook National University
Daegu, Jung-gu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
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Responsible Party: Dong Ho Park, Department of Ophthalmology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT01992510    
Other Study ID Numbers: KNUH2013
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013