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NCT Number: NCT02423382

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

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

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicone Oil Removal

Procedure

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

Primary outcomes

  1. The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months

    Time frame: 1 day before silicone oil removal and 2 months after silicone oil removal.

Secondary outcomes

  1. The changes from baseline in the retinal vessel width by Oxymap at 2 months

    Time frame: 1 day before silicone oil removal and 2 months after silicone oil removal.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2015
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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