Status:
UNKNOWN
Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
Lead Sponsor:
GuangZhou WeiShiBo Biotechnology Co., ltd
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Retinal Detachment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the multi-center clini...
Detailed Description
Previous clinical trial have demonstrated that foldable artificial vitreous body (FCVB),with balanced salt solution (BSS) filled in 11 patients during three-months observation,or silicone oil filled i...
Eligibility Criteria
Inclusion
- age range from 18 to 65, Refractive error less than ±3D
- Corrected visual acuity less than 0.05
- ocular axial length is 16 to 25mm
- severe retinal detachment that can not be treated by current artificial vitreous body:
- Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
- Severe unilateral ocular rupture injuries result in retina or choroid defect.
- Giant posterior scleral rupture injuries that can not be repaired.
- Silicone oil can't be taken out for a long time with incomplete reattachment.
- Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.
- Participants can understand the aim of this clinical trial and sign the informed consent form
Exclusion
- Participants have a silica gel allergy or scar diathesis
- entophthalmia
- uveitis
- The contralateral eye suffered from intraocular surgery
- uncontrollable the other eye diseases
- Corrected visual acuity of contralateral eye less than 0.4
- Proliferative diabetic retinopathy
- the lens of target eye is transparent
- Serious heart, lung, liver and kidney dysfunction
- pregnancy, preparation for pregnancy during clinical trial and breast-feeding female
- drug abuse or alcoholism
- participated the other drug or medical devices clinical trial before screening of this trial
- Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc.
- Patient adherence is so poor that study procedures can not be finished
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01261533
Start Date
September 1 2010
End Date
June 1 2014
Last Update
May 23 2013
Active Locations (9)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
2
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
3
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
4
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000