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Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade

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ClinicalTrials.gov Identifier: NCT02423382
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Bingsheng Lou, Sun Yat-sen University

Brief Summary:
The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.

Condition or disease Intervention/treatment Phase
Retinal Detachment Procedure: Silicone oil removal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap
Study Start Date : February 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
3-6 months group
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.
Procedure: Silicone oil removal
The patients in each group will receive the same procedure of silicone oil removal.

6-9 months
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.
Procedure: Silicone oil removal
The patients in each group will receive the same procedure of silicone oil removal.

>9 months
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.
Procedure: Silicone oil removal
The patients in each group will receive the same procedure of silicone oil removal.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT02423382


Locations
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China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Xiaofeng Lin, MD, Ph.D Zhongshan Ophthalmic Center at Sun Yat-sen University

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Responsible Party: Bingsheng Lou, DR., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02423382    
Other Study ID Numbers: SLT201405
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Bingsheng Lou, Sun Yat-sen University:
silicone oil
retinal saturation
retinal blood flow
retinal detachment
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Diseases
Eye Diseases
Silicon
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs