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

NCT ID: NCT02423382

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Retinal Detachment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Silicone oil removal

Intervention Type PROCEDURE

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

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.

Group Type OTHER

Silicone oil removal

Intervention Type PROCEDURE

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

>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.

Group Type OTHER

Silicone oil removal

Intervention Type PROCEDURE

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

Interventions

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Silicone oil removal

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Bingsheng Lou

DR.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofeng Lin, MD, Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center at Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SLT201405

Identifier Type: -

Identifier Source: org_study_id

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