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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02423382
Enrollment
49
Registered
2015-04-22
Start date
2014-02-28
Completion date
2014-10-31
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

silicone oil, retinal saturation, retinal blood flow, retinal detachment

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.

Interventions

The patients in each group will receive the same procedure of silicone oil removal.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months1 day before silicone oil removal and 2 months after silicone oil removal.

Secondary

MeasureTime frame
The changes from baseline in the retinal vessel width by Oxymap at 2 months1 day before silicone oil removal and 2 months after silicone oil removal.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026