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

April 21, 2015 updated by: Bingsheng Lou, Sun Yat-sen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The patients in each group will receive the same procedure of 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
The patients in each group will receive the same procedure of 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
The patients in each group will receive the same procedure of silicone oil removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
1 day before silicone oil removal and 2 months after silicone oil removal.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
1 day before silicone oil removal and 2 months after silicone oil removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Xiaofeng Lin, MD, Ph.D, Zhongshan Ophthalmic Center at Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLT201405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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