1. What is the material of FCVB?
A: FDA-approved high molecular medical polymer.
2. What is the longest period of intraocular implantation of FCVB?
A: The first FCVB implantation surgery was conducted in June,2009 .
3. Can only silicone oil be injected into the FCVB balloon? Why not inject normal saline?
A: Both Silicone oil and normal saline can be injected into the FCVB balloon.
Due to the nano-pores in the FCVB balloon, the injection of normal saline will leak, and the proteins in the anterior chamber will infiltrate into the balloon.While there is no obvious leakage by injecting silicone oil .
4. Is FCVB resistant to lasers?
A: FCVB can tolerate YAG laser. For patients with vision, it is better to use laser treatment when the exudate membrane is relatively thin. As the membrane is thicker in later stage, it requests stronger power, which will be more risky to the FCVB.
5. What is the transmittance of FCVB?
A: It can reach more than 95% of the light transmittance of natural vitreous body.
6.What is the oxygen permeability of FCVB?
A: The direct injection of silicone oil will lead to unstable oxygen balance in the vitreous body. In comparison, FCVB can reduce the influence of silicone oil, and do not affect the function of the ciliary body, maintaining the aqueous humor circulation.
7. What is the thickness of FCVB?
A: Different parts of FCVB have different thicknesses. The thickness of the optical zone is 0.3±0.1 mm, and the thickness of the balloon is 0.2±0.1 mm.
8. Can FCVB be expanded? Why is there a recommended amount of silicone oil? What is the maximum amount that can be injected?
A: FCVB can be expanded. The recommended amount of silicone oil refers to the amount of silicone oil that the balloon maintains its natural form after silicone oil implantation, but it should not exceed the maximum injection amount of each model.
9. What are the advantages and disadvantages of FCVB ? Will the silicone oil emulsification happen after FCVB implantation?
A: The advantage of FCVB is that it 360° supports the retina , isolates the direct contact between silicone oil and tissue, avoids silicone oil emulsification, preserves the posterior chamber space, does not interfere with the ciliary body, and maintains intraocular pressure.
The disadvantage of FCVB is that the surgical incision is larger than that of simply injecting silicone oil.
There is no clinical case of silicone oil emulsification after FCVB implantation
10. What is the difference between the first and second generation of FCVB?
Answer: The first generation of FCVB is exactly the same shape as the natural vitreous body, and the lens surface is fovea.
The second-generation lens surface is flat, which can preserve the space of the posterior chamber, does not interfere with the ciliary body, and maintains intraocular pressure.
11. Does FCVB stimulate the retina? Will it cause nerve damage?
A: FCVB has a top-pressure effect on the retina, which can stay in the eye for a long time without harm to nerves.
12. Why can the FCVB drainage valve close itself?
A: The special design of the drainage valve makes it have a self-closing function.
13. Is FCVB puncture resistant?
A: Most parts of FCVB are relatively thin and not resistant to puncture. The drainage valve part is thicker, resistant to puncture, and has a self-closing function after puncture.
14. What is the FCVB sealing position?
Answer: It is a process in the production process of FCVB. It is located on the opposite side of the root of the drainage tube and close to the lens plane. Because it is in the rear space, it does not adhere to the intraocular tissue.
15.How does FCVB distinguish the front and back side?
A: The front is the lens plane, which is the flat side, and the reverse side is the retinal plane, which is the spherical side.
16. Why does the joint line appear in FCVB?
A: The joint line is formed by the contact between the upper and lower parts of the mold in the production process.
17. What is the specific function of the drainage valve?
To adjust the volume of silicone oil injected into the balloon.
It can be secondary injected or withdrawn.
18. Are there similar products abroad?
A: There is no similar product abroad, and it is creation in the world.
19. How does FCVB work?
①FCVB can support the retina and maintain the shape of the eyeball;
(2) FCVB can avoid emulsification and displacement of silicone oil;
③ The second generation of FCVB products can press the anterior chamber, and don’t affect the ciliary body, so as to stabilize the intraocular pressure.
20. What are FCVB Indications?
- 18 to 65 years old, male or female;
- Eye vision <0.05;
- The axial length of the surgical eye is 16 to 28 mm;
- The existing vitreous substitute cannot be used for treatment (unilateral eye) (any of the following conditions is sufficient): a.Severe unilateral penetrating injury or penetrating injury, complex retinal and/or choroidal detachment due to retinal rupture, retinal choroidal hemorrhage, etc.; b.Severe unilateral rupture of the eyeball, resulting in retinal and/or choroidal defects; c.Large posterior scleral laceration of unilateral eyeball, which cannot be repaired; d. Long-term filling of silicone oil cannot be removed, and retinal reattachment is incomplete; e.After two or more retinal detachment surgeries and silicone oil packing, the retina is detached again after silicone oil removal.
21. Is it mandatory to meet the indications listed in the instruction manual for FCVB implantation ?
A: Usage beyond the instructions needs to be approved by the ethics committee or new technical committee.
22. What kind of patients can use FCVB?
A: Patients with severe ocular trauma and silicone oil-dependent eyes.
23. Will FCVB surgery cause sympathetic ophthalmia?
A: No. In past clinical trials of FCVB surgery, no cases of sympathetic ophthalmia were found. The longest relevant clinical observation period is 12 years and the shortest is 6 years.
24.What is the working life for FCVB?
A: FCVB can be used for life. Up to now, Cases observed in our clinical trials have been 10+ years after FCVB implantation without any obvious abnormality.
25. How long is the follow-up period required after FCVB?
A: We recommend regular follow-up according to the patient’s pocket book.
26. Are there any clinical trials for FCVB products?
A: Yes. We conducted 15 exploratory studies on the treatment effects of severe retinal detachment at the Zhongshan Eye Center. On the basis of this study, in order to determine the safety and efficacy of FCVB, a multi-center clinical trial of 122 procedures has been further conducted in 9 hospitals in China.
27. What are the results of the multi-center clinical trial?
A: The retinal reattachment rate at 24 weeks and the reattachment rate at 52 weeks is 83%, and the adverse reactions are lighter than those of simple silicone oil.
28. Based on preliminary clinical trials, the contraindications for CFDA approval are as follows:
A: (1) Those who are known to be allergic to silicone, those with scar constitution;
(4) The lens of the surgical eye is transparent;
(5) Proliferative diabetic retinal disease;
(6) Corrected visual acuity of the contralateral eye ≤ 0.4;
(7) The contralateral eye has a history of intraocular surgery;
(8) Other ophthalmic concomitant diseases that cannot be controlled;
(9) Severe renal and liver damage and/or severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system diseases, etc.);
(10) Women who are pregnant, preparing to become pregnant or breastfeeding;
(11) A history of drug abuse or alcoholism.
29. When is the right time for FCVB implantation?
A: The best time for FCVB surgery is 7-14 days after injury, when the intraocular bleeding stops and the blood becomes thinner, making it easy to cut and flush.
30. What is the size of FCVB surgical incision?
A: The incision is generally 3.5-4.5mm according to the FCVB model and L-shaped .
31. What is the viscosity of the silicone oil injected into the balloon during FCVB implantation?
A: The viscosity of silicone oil is measured in centimeters. For FCVB implantation, high-quality silicone oil above 5000 centimeters should be selected; at the same time, a 19G silicone oil needle should be selected for filling.
32. What are the possible adverse reactions after FCVB?
A: Such as postoperative hyphema, high intraocular pressure and low intraocular pressure, fibrous membrane, drainage tube exposure and balloon rupture accompanied by leakage of silicone oil, etc. In addition to the inherent adverse reactions of ocular trauma, the adverse reactions of FCVB can be greatly reduced by strict training.
33. Can patients without iris use FCVB, and will FCVB move forward?
A: Patients without an iris can also use FCVB. The vertical diameter of FCVB is larger than the anteroposterior diameter, and generally does not move forward, but the ciliary part must be fully treated to avoid the anterior PVR pulling and leading to forward movement. At the same time, the coordination of body position is also very important within three months after the operation.
34. Does the patient have vision in the surgery eye after FCVB implantation?
A: The main function of FCVB is to maintain the residual structure of the eyeball, and it has no therapeutic effect on vision. Successful surgery can maintain vision.
35. How to choose the model of FCVB?
A: The corresponding model is judged according to the anterior and posterior diameter of the eyeball. At the same time, the injury history, surgical history and refractive state of the eye should be comprehensively considered. After the surgeon completes the PPV, the model should be reconfirmed.
36. How to choose an implanter?
A: According to the product model. PI-3 can be implanted with AV-13.5P, AV-15P, AV-17P, and PI-4 can be implanted with AV-10P and AV-12P.
37. Can FCVB be removed after implantation?
A: If necessary, the balloon is easy to remove and will not adhere to the retina. Before removal, the silicone oil should be withdrawn as much as possible to empty the balloon before removal. When taking out, the scleral incision was enlarged to 2mm, and the drainage tube was pulled. When the balloon was blocked, please cut with scissors and taken out directly.
38. The patient’s eyeball has different axial lengths, and different models of FCVB products also have different sizes. Does the FCVB have to fit the retina?
A: The thickness of all FCVB products is 180μm, and the products are made of safe and soft materials, which can basically fit the inner wall of the eyeball well. For proper intraocular pressure, a certain gap is generally reserved between the FCVB product and the retina.
39. Does the vitreous body need to be cleaned during the operation?
A: Yes, it is treated like ordinary silicone oil injection, otherwise it will cause the anterior PVR to stretch the balloon and cause a shallow anterior chamber.
40.What is the specific role of periiris incision at 4 o‘clock and 8 o’clock?
A: It is to strengthen the communication between the anterior and posterior chambers, so that the bleeding and inflammatory exudation can be quickly absorbed, and the aqueous humor in the posterior chamber will also be able to enter the anterior chamber.
41. How to prevent the FCVB balloon from tilting?
A: The FCVB ballon should be straight when folded. After implanting into the eye, the position should be confirmed at first. If there is a tilt after silicone oil filling, it should adjust again.
42. What are the folding skills?
A: 1. The three fingers must work together. Use the thumb, the index finger and the middle finger to press on both sides. The half arc should be very smooth and not wrinkled. The top of the half arc is at the root of the drainage tube without extra parts.
2. When folded, the first two-thirds, the second half folded, long willow leaf shape, and there should be no loosening during the turning process.
3. Hold the long axis of the product obliquely with the tweezers, put most of the product into the implanter cavity at one time, and prevent the folded product from loosening, push the rest of the product in the second time, and the drainage valve is now facing upwards. No twist.
43. How to adjust the FCVB balloon position?
A: Use the slender iris restorer or lens adjustment hook to go deep into the distal end of the balloon (6 o’clock position of the eyeball) to rotate and adjust the position.
It is too close to adjust the position.
44. Can it be sucked out if there are large air bubbles?
Answer: Yes, large air bubbles can be drawn out with a blunt water injection needle from the position where the silicone oil is injected into the drainage valve to the edge of the air bubbles. Smaller air bubbles do not need to be treated. The wall of the balloon has micropores of about 300 nm, and the small air bubbles can be gradually absorbed . It is forbidden to use sharp instruments to suck air.
45. How much silicone oil is appropriate to inject?
A: It depends on the doctor’s experience due to the different volume of the vitreous body of each patient.It is necessary to refer to the recommended amount of silicone oil and the maximum amount of silicone oil injection provided by the manufacturer.
47. Can FCVB surgery be performed with poor ciliary body function?
Answer: Yes. However, it is necessary to inform the patient that there is still a risk of eye atrophy after surgery, and he needs to inject viscoelastic into the anterior chamber after surgery to maintain intraocular pressure and wait for the slow recovery of ciliary body function.
47. Can FCVB surgery be performed with ciliary body detachment?
A: Yes,can. The ciliary body needs to be sutured and reset first, and the intraocular pressure will be better after the operation.
48. How long does FCVB surgery usually take?
Answer: It will refer to the specific condition of the patient, usually take about 40 minutes to 80 minutes.
49. Can the appearance of the eyeball recover to normal after FCVB implantation? Can FCVB implantation prevent eyeball atrophy?
A: For patients without eyeball atrophy, FCVB implantation can prevent eyeball atrophy; for patients with severe eyeball atrophy, FCVB can preserve the patient’s eyeball and maintain a good appearance.
50. Why is viscoelastic injected after surgery?
A: It is to occupy the space of the anterior and posterior chambers, leaving enough time for the recovery of the ciliary body.
51. Why use optical fiber to observe the fundus?
Answer:It is to observe the retinal reattachment and local conditions of the fundus to confirm the effect of the operation.
52. What are the specific observation contents of the application of optical fiber in surgery?
Answer: ① to observe if there is any air bubbles in the balloon ② whether the balloon is wrinkled or not ③ retinal reattachment situation, whether there is local ischemia etc.
53. Are there any requirements for post-operative posture?
Answer: Strictly prone position one week after surgery, side or prone position within 3 months, normal position after 3 months.
54. Can FCVB be implanted with low intraocular pressure?
55. How to avoid retinal ischemia caused by excessive pressure on the retina after FCVB implantation?
Answer: After FCVB implantation, the intraocular pressure is usually required to be controlled at about 15mmHg, which is different from the 20mmHg required by traditional surgery. If too much silicone oil is injected, it will cause excessive pressure, and in the long run, problems such as ciliary body damage and corneal collapse will occur. The reason is that excessive top pressure can cause the ciliary body to reduce or even completely lose the function of secreting aqueous humor.
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