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CompletedNCT02423382Updated Apr 22, 2015

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

An interventional study of Silicone oil removal in Retinal Detachment, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Retinal Detachment

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Keywords

  • silicone oil
  • retinal saturation
  • retinal blood flow
  • retinal detachment
03

In context

Retinal Detachment

207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.

This study's enrollment of 49 is close to the median of 50 across 136 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Other
    3-6 months group

    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.

    Procedure: Silicone oil removal

  • Other
    6-9 months

    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.

    Procedure: Silicone oil removal

  • Other
    >9 months

    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.

    Procedure: Silicone oil removal

Interventions

  • ProcedureSilicone oil removal

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

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What researchers measure

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.

07

Study locations

1 site
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510060, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02423382
Lead sponsor
Sun Yat-sen University
Responsible party
Bingsheng Lou (DR., Sun Yat-sen University) — Principal investigator
First posted
Apr 22, 2015
Start date
Feb 2014
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Apr 22, 2015

Study contacts

Xiaofeng Lin, MD, Ph.D
study chair · Zhongshan Ophthalmic Center at Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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