Wistia video thumbnail


RETISERT®: surgical procedure for implantation





1

The surgical procedure for intravitreal implantation of RETISERT® is typically performed under local anesthesia. If clinically indicated, general anesthesia may be used. If the eye has had a previous vitrectomy, a pars plana infusion line is recommended to minimize globe collapse.



2

A conjunctival incision is made at the limbus, and hemostasis is achieved using a bipolar diathermy.



3

RETISERT® is prepared by passing a double-armed 8-0 Prolene suture through the hole in the anchoring strut of the implant. A single knot is tied over the suture strut.



4

The implant (and infusion line if the patient had a previous vitrectomy) should be placed as to avoid areas with evidence of peripheral traction, retinal detachment, or snow banking. Choose a site with healthy conjunctiva that will cover the sutures used to close the wound, avoiding areas with thinned conjunctiva. A 20-gauge microvitreoretinal blade is used to enter the sclera 3.75 to 4 mm posterior to the limbus.



5

The incision is then enlarged to approximately 3.0 to 3.5 mm circumferentially. Any prolapsed vitreous should be excised.*



6

The lips of the sclerotomy incision are held open to confirm that a full-thickness incision of the underlying choroid and pars plana has been made. If bridging choroid is present, it should be cut to avoid placement into the suprachoroidal space.



7

The strut of the implant is then grasped with smooth-bladed forceps or a needle holder and implanted into the eye with the drug tablet (top surface of the implant) facing the front of the eye. Care is taken at this stage not to perforate or damage the membrane covering the drug tablet.



8

Excise* any prolapsed vitreous, ensuring that the implant is not covered with any tissue before it is permanently tied in place.



9

Each needle on the double-armed 8-0 Prolene suture is passed through the appropriate side of the scleral incision. The anchoring suture is then tied, leaving the ends long. The strut of the implant should remain deep in the wound. If while tying the anchoring suture the strut appears to extrude or be pulled into the wound, release the suture and push the implant deeper into the vitreous. If this occurs on the next attempt to tie the anchoring suture, it may be necessary to tie the adjacent 9-0 Prolene sutures prior to tying the anchoring suture.



10

Interrupted 9-0 Prolene sutures are placed on each side of the anchoring suture and tied over the tails of the anchoring suture, to secure the tails in a flat position on the sclera. The interrupted sutures are rotated to bury the knots. The anchoring suture is not rotated. The wound should be closed so that no part of the implant strut is visible. If necessary, balanced salt solution is injected through the pars plana to restore intraocular pressure.



11

The implant is then inspected with the binocular indirect ophthalmoscope to verify intravitreal placement. The conjunctiva is closed with plain gut sutures or other suture material of the surgeon’s choice.



12

A subconjunctival antibiotic and steroid injection will be administered.†



This description of the surgical procedure is included for educational and illustrative purposes only. It is not intended as medical advice or a recommendation by Bausch + Lomb of any particular surgical procedure.


* Using an automated vitrectomy device or a Weck-Cel sponge with Wescott utility scissors.
† Medications to be used prior to, during, and immediately after the surgical procedure are:
  • Standard dilating drops cyclopentolate HCl 1% and phenylephrine 2.5% (or equivalent) for dilation; administered 2 to 4 times beginning 1/2 to 2 hours prior to surgery; use of flurbiprofen 0.03% (or equivalent) is optional
  • Balanced salt irrigating solution to be injected through the surgical incision to restore intraocular pressure at the end of surgery, if necessary
  • An antibiotic (eg, cefazolin 50-100 mg, or vancomycin 20 mg) and a steroid (eg, dexamethasone 5 mg/0.5 mL) to be injected subconjunctivally at the end of surgery




Indication and Usage





RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is used to treat an inflammation in the back of the eye that is not caused by an infection, called chronic non-infectious uveitis.

.

Important Safety Information





  • Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg should not be used if you have an infection of the eye from viruses, bacteria, fungi or fungal diseases.

  • After receiving the Retisert® implant, you should periodically see an eye doctor for follow-up examinations of both eyes.

  • As with any surgical procedure, there is risk involved. Complications can include injury to the eye; infection; mechanical complication, movement or ejection of the implant; and wound complications following the surgery.

  • After receiving the Retisert® implant, nearly all patients will experience an immediate and temporary decrease in vision in the implanted eye that lasts for approximately 1 to 4 weeks following the surgery.

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, approximately 77% of patients require medications to lower pressure in the eye, and approximately 37% of patients will require a surgical procedure to control pressure in the eye.

  • Long-term use of corticosteroids may result in an increased risk of glaucoma (high pressure in the eye).

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, nearly all patients who have not already had cataracts will develop them and require surgery.

  • The most common side effects, occurring in 50-90% of patients, were cataract, increased pressure in the eye, surgery complications and eye pain. Headache was also reported in greater than 33% of patients



Please see full Prescribing Information for Retisert®

You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.