Retinal DetachmentNCT02423382
Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade
A study testing Silicone oil removal in people with Retinal Detachment, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Silicone oil removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- initial silicone oil tamponade duration of more than 3 months
- transparent reflecting media
- intraocular pressure (IOP) between 11 and 21mmHg
- complete retinal re-attachment
- healthy contralateral eye.
Who cannot join
- severe refractive media opacity (serious keratoleukoma and cataracts)
- silicone oil emulsification
- ocular hypertension
- retinal detachment
- retinal scar within the main vascular arch
- any ocular disease and any history of surgery in the contralateral eye
- any type of systemic disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap
The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.
Read the detailed description
Silicone oil is the first choice treatment for long-term vitreous replacement in complicated cases of retinal detachment. However, it will cause various problems for permanent tamponade, such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition, silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and mechanical pressure of the silicone oil on the retina may influence retinal blood flow and, and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the retina. In this study, the investigators utilized a noninvasive measurement (Oxymap, Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and diameter in retinal vessels in complicated retinal detachment cases.
- Conditions
- Retinal Detachment
- Being tested
- Silicone oil removal
- Keywords
- silicone oil, retinal saturation, retinal blood flow, retinal detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone oil removalProcedure or surgery
The patients in each group will receive the same procedure of silicone oil removal.
| Study group | Role | What they receive |
|---|---|---|
| 3-6 months group | Other | In this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 3-6 months. Receives: Procedure: Silicone oil removal |
| 6-9 months | Other | In this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 6-9 months. Receives: Procedure: Silicone oil removal |
| >9 months | Other | In this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for more than 9 months. Receives: Procedure: Silicone oil removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months
Measured: 1 day before silicone oil removal and 2 months after silicone oil removal.
Secondary outcomes (1)
The changes from baseline in the retinal vessel width by Oxymap at 2 months
Measured: 1 day before silicone oil removal and 2 months after silicone oil removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bingsheng Lou, Sun Yat-sen University
- Investigators
- Xiaofeng Lin, MD, Ph.D, Study chair, Zhongshan Ophthalmic Center at Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423382
- Sponsor's protocol ID
- SLT201405
- Status last verified
- Apr 2015
- First submitted
- 14 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap
- ClinicalTrials.gov ID
- NCT02423382
- Acronym / sponsor ID
- SLT201405
- Conditions
- Retinal Detachment
- Keywords
- silicone oil, retinal saturation, retinal blood flow, retinal detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Apr 2015 (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 purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.
Detailed description
Silicone oil is the first choice treatment for long-term vitreous replacement in complicated cases of retinal detachment. However, it will cause various problems for permanent tamponade, such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition, silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and mechanical pressure of the silicone oil on the retina may influence retinal blood flow and, and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the retina. In this study, the investigators utilized a noninvasive measurement (Oxymap, Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and diameter in retinal vessels in complicated retinal detachment cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-6 months group | Other | Procedure: Silicone oil removalIn this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 3-6 months. |
| 6-9 months | Other | Procedure: Silicone oil removalIn this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 6-9 months. |
| >9 months | Other | Procedure: Silicone oil removalIn this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for more than 9 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- initial silicone oil tamponade duration of more than 3 months
- transparent reflecting media
- intraocular pressure (IOP) between 11 and 21mmHg
- complete retinal re-attachment
- healthy contralateral eye.
Key exclusion criteria (8 listed)
- severe refractive media opacity (serious keratoleukoma and cataracts)
- silicone oil emulsification
- ocular hypertension
- retinal detachment
- retinal scar within the main vascular arch
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 |
|---|---|---|
| Silicone oil removalThe patients in each group will receive the same procedure of silicone oil removal. | Procedure or surgery | 3-6 months group, 6-9 months, >9 months |
Primary outcome
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months
Time frame: 1 day before silicone oil removal and 2 months after silicone oil removal.
1 secondary outcome
The changes from baseline in the retinal vessel width by Oxymap at 2 months
Time frame: 1 day before silicone oil removal and 2 months after silicone oil removal.
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 22 Apr 2015.
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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.
Xiaofeng Lin, MD, Ph.D study chair
Zhongshan Ophthalmic Center at Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone oil removal in people with Retinal Detachment, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 8 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 22 Apr 2015. 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 China. 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?
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months (time frame: 1 day before silicone oil removal and 2 months after silicone oil removal.). 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 22 Apr 2015.