The Exploratory Clinical Trials for the Feasibility, primary Safety and Efficacy of Foldable Capsular Vitreous Body

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TNC-09000396

Enrollment

Unknown

Registered

2009-05-16

Start date

2009-05-20

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic retinal detachment, visual acuity worse than finger count, ciliary dysfunction, induced eyeball atrophy

Interventions

FCVB team:the vitreal cavity is tamponaded with the foldable capsular vitreous body (FCVB)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Refractive error less than +/-3D; 2. Visual acuity worse than finger count; 3. Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length in 16 to 25mm; 4. Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Serious heart, lung, liver and kidney dysfunction; 2. Serious eye inflammation; 3. Silicone oil filled eyes; 4. The contra lateral eye is non-functional; 5. Patients with diseases that the researchers consider not suitable participated in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Complete retinal reattach rate;	—

Secondary

Measure	Time frame
Morphological changes of FCVB and the eye ball;ocular inflammatory response;Change of Angle of anterior chamber and ciliary body;visual acuity;the number of corneal endothelial;axial length;intraocular pressure;	—

Countries

China

Contacts

Public ContactQianying Gao

Zhongshan Ophthalmic Center, Sun Yat-Sen University

gaoqy@mail.sysu.edu.cn+86 020 87330490

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026