Eye Injuries Clinical Trial
Official title:
Multi-center Clinical Observation of FCVB in Guangdong Province
NCT number | NCT03908515 |
Other study ID # | FCVB 2019 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | May 31, 2020 |
This study provides further theoretical guidance for clinical application of FCVB through observing and collecting various indicators before and after surgical treatment of the FCVB in the real world.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with the diagnose that severe retinal detachment and cannot be cured with existing vitreous substitutes, or silicone oil dependent eye accompanied with silicone oil emulsification, or eyeball atrophy meanwhile patients strongly demand keeping eyeball. 2. Patients agree to receive FCVB implantation surgery. Exclusion Criteria: 1. Patients whose urine pregnancy test are positive. 2. Patients whose FCVB have been removed and switched to other alternative treatments. 3. Patients whom the investigator consider are not suitable for this clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center of Sun yat-sen Universtiy | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corneal transverse diameter change | Determine the degree of eyeball atrophy through the change of transverse Diameter of the cornea | Corneal transverse diameter change from 1day before surgery to 1 year after surgery | |
Primary | Ocular protrusion change | Determine the degree of eyeball atrophy through the ocular protrusion change | Ocular protrusion change from 1day before surgery to 1 year after surgery | |
Secondary | Visual acuity | Postoperative visual acuity | 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery | |
Secondary | Intraocular pressure | Postoperative intraocular pressure | 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery | |
Secondary | Local inflammatory response | Evaluation of postoperative complications | 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery | |
Secondary | Patients satisfaction | Postoperative patients satisfaction | 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery |
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