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

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

Detailed Description
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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.

Official Title
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Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap

Conditions
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Retinal Detachment

Intervention / Treatment
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* Procedure: Silicone oil removal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3-6 months group<br>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<br>* The patients in each group will receive the same procedure of silicone oil removal.<br>|
| Other: 6-9 months<br>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<br>* The patients in each group will receive the same procedure of silicone oil removal.<br>|
| Other: >9 months<br>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<br>* The patients in each group will receive the same procedure of silicone oil removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months |  | 1 day before silicone oil removal and 2 months after silicone oil removal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes from baseline in the retinal vessel width by Oxymap at 2 months |  | 1 day before silicone oil removal and 2 months after silicone oil removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silicone oil, retinal saturation, retinal blood flow, retinal detachment