Silicone TamponadeNCT01992510
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes
An observational study of Silicone Tamponade, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 33 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Silicone Tamponade
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jan 2013
- 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 33 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: silicone tamponade patients
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, School of Medicine, Kyungpook National University
Daegu, Jung-gu, 700-721
About this study
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.
- Conditions
- Silicone Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| silicone oil fiiled eye | those with a condition | |
| fellow eye | the contralateral eye in the same patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP(intraocular pressure) at each time point during the change in body position
Measured: 100 minutes
Secondary outcomes (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
Measured: 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silicone TamponadeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ho Park, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992510
- Sponsor's protocol ID
- KNUH2013
- Status last verified
- Dec 2013
- First submitted
- 11 Nov 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes
- ClinicalTrials.gov ID
- NCT01992510
- Acronym / sponsor ID
- KNUH2013
- Conditions
- Silicone Tamponade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone oil fiiled eye | – | –those with a condition |
| fellow eye | – | –the contralateral eye in the same patient |
Who may qualify
- Ages
- 33 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- silicone tamponade patients
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean IOP(intraocular pressure) at each time point during the change in body position
Time frame: 100 minutes
1 secondary outcome
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
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 23 Dec 2013.
Related trials for Silicone Tamponade
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Silicone Tamponade, run by Kyungpook National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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 23 Dec 2013. 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 South Korea. 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?
Mean IOP(intraocular pressure) at each time point during the change in body position (time frame: 100 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2013.