Eye Injuries Clinical Trial
Official title:
Multi-center Clinical Observation of FCVB in Guangdong Province
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.
1. Research purpose: Collect and analyze the medical data in clinical work, in order to
provide further theoretical guidance for the clinical application of FCVB.
2. Inclusion criteria: 1) Patients with severe retinal detachment, cannot be cured with
existing vitreous substitutes, and are scheduled for FCVB implantation surgery; 2)
Patients with silicone oil dependent eye, silicone oil emulsification, and chooses FCVB
surgery; 3) Patients whose eyeball Atrophy, and strongly demand eye protection.
3. Exclusion criteria: 1) Patients with positive urine pregnancy test; 2) Patients with
FCVB removed and switched to other alternative treatments; 3) Patients the investigator
consider are not suitable for this clinical trial.
4. Endpoint Primary endpoint: Changes in corneal transverse diameter and ocular protrusion
after 1 year of FCVB implantation.
Secondary endpoints: visual acuity and intraocular pressure; local inflammatory response
and complications evaluation; satisfaction investigated by questionnaire survey.
5. Process Before surgery, collecting the patient's medical history and pre-operative
related specialist examination data and subjective opinions of doctors on surgical
indications. Recording the surgical procedure, intraoperative complications. After
surgery (3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year and
1 year follow-up every year), using visual acuity chart, slit lamp microscope,
ophthalmoscope, intraocular pressure, Hertel exophthalmometer, vernier caliper to
observe the patient's visual acuity, local inflammatory reaction, intraocular pressure
and eyeball atrophy changes.
6. Efficacy evaluation Main indicators: the changes of corneal transverse diameter and
ocular protrusion were observed 1 year after FCVB implantation.
Secondary indicators: visual acuity and intraocular pressure; local inflammatory
response and complications evaluation; satisfaction investigated through questionnaire
survey.
7. Safety evaluation Adverse events that occurred during all studies.
8. Termination criteria During the clinical trial, the clinical trial shall be terminated
in any of the following cases; (1) FCVB cannot be implanted (2) Subjects who fail to
comply with the program requirements (including loss of follow-up) are subject to
termination by the study physician; (3) a female patient who is intentionally pregnant
or a female subject who has been confirmed to have been pregnant; (4) Participated in
other clinical trials after participating in this clinical trial; (5) Adverse events or
serious adverse events occurred during the trial and were unable to continue
participating in the study; (6) The subject withdraws the informed consent or requests
termination of the trial for some objective reason.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04521283 -
Visual Outcome of Traumatic Posterior Segment Complications
|
||
Completed |
NCT05771467 -
Evaluation of Retinal Microvascular Change That May Develop in Patients After Open Globe İnjury With Optical Coherence Tomography (OCTA)
|
||
Completed |
NCT00129077 -
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
|
N/A | |
Completed |
NCT01490593 -
Canadian Eye Injury Registry
|
N/A | |
Recruiting |
NCT03706560 -
Professional Consequences of Ocular Trauma Hospitalized at the Hospital Centre of Clermont-Ferrand
|
||
Not yet recruiting |
NCT05164588 -
A Prospective Study of Traumatic Eye Injuries in the Period From January 2022 to June 2022 in Sohag University Hospitals
|
||
Completed |
NCT02638025 -
Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
|
N/A | |
Completed |
NCT04595357 -
"Iris Shelf" Technique for Intraocular Foreign Bodies Removal
|
||
Completed |
NCT04837534 -
Improving the Follow up Rate for Pediatric Patients
|
N/A | |
Not yet recruiting |
NCT06174415 -
An Exploratory Study of Visual Function Rehabilitation in Patients With Ocular Trauma
|
N/A | |
Completed |
NCT00598299 -
Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Auto-Serum and Cord Blood Serum
|
N/A | |
Terminated |
NCT00211367 -
Treatment of Radiation Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
|
Phase 2 |