Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade
1 other identifier
interventional
49
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedApril 22, 2015
April 1, 2015
8 months
April 14, 2015
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months
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
1 day before silicone oil removal and 2 months after silicone oil removal.
Study Arms (3)
3-6 months group
OTHERIn this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 3-6 months.
6-9 months
OTHERIn this group, the patients will recieve the surgery of silicone oil removal when silicone oil has been filled into eye for 6-9 months.
>9 months
OTHERIn 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.
Interventions
The patients in each group will receive the same procedure of silicone oil removal.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaofeng Lin, MD, Ph.D
Zhongshan Ophthalmic Center at Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR.
Study Record Dates
First Submitted
April 14, 2015
First Posted
April 22, 2015
Study Start
February 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 22, 2015
Record last verified: 2015-04