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

Sun Yat-sen University

Status: Completed

Conditions: Retinal Detachment

Treatments: Procedure: Silicone oil removal

Study type: Interventional

Funder types: Other

Identifiers

NCT02423382

SLT201405

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

3-6 months group

Other group

Description:

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.

Treatment:

Procedure: Silicone oil removal

6-9 months

Other group

Description:

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.

Treatment:

Procedure: Silicone oil removal

>9 months

Other group

Description:

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.

Treatment:

Procedure: Silicone oil removal