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

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: Silicone oil removal

• Registration Number: NCT02423382
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-21
• Last Update Submitted: 2015-04-21
• Study First Posted: 2015-04-22
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-6 months group	Silicone oil removal	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.
>9 months	Silicone oil removal	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.
6-9 months	Silicone oil removal	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China