search
Back to results

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

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Silicone oil removal
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring silicone oil, retinal saturation, retinal blood flow, retinal detachment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

3-6 months group

6-9 months

>9 months

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2015
Last Updated
April 21, 2015
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02423382
Brief Title
Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade
Official Title
Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
silicone oil, retinal saturation, retinal blood flow, retinal detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-6 months group
Arm Type
Other
Arm Description
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.
Arm Title
6-9 months
Arm Type
Other
Arm Description
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.
Arm Title
>9 months
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Silicone oil removal
Intervention Description
The patients in each group will receive the same procedure of silicone oil removal.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lin, MD, Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center at Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs