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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423382
• Other study ID #: SLT201405
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: April 21, 2015
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No