The Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body: a Multi-center Exploratory Clinical Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-10001031

Enrollment

Unknown

Registered

2010-08-01

Start date

2010-09-01

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 equel to or better than light perception, ciliary dysfunction, induced eyeball atrophy

Interventions

FCVB TEAM:the vitreal cavity is tamponaded with the foldable

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. age range from 18 to 65, Refractive error less than +/-3D; 2. Visual acuity equel to or better than light perception; 3. Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm Signed the informed consent form

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
ocular inflammatory response;	—

Secondary

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

Countries

China

Contacts

Public ContactQianying Gao

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

Outcome results

None listed

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