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SCLERAL BUCKLE (Circling band)

Non-active implantable medical device

Описание

Circling band is made of elastic, medical grade silicone rubber. Two marks (small prominencies) are provided keeping the 60 mm distance between them. They are located at the ends of the circling band. Marks are aimed to standardize compression of the eyeball. Circling band exhibits circular compression of the sclera at the eyeball equator. Shortening the eyeball circumference it squeezes the sclera and forms an artificial ora serrata.

Показания

  • The circling band prevents detachment of the retina. It secures sclerotomy during pars plana vitrectomy. Cerclage also facilitates isolation of the vitreous body. It treats detachment of the retina of different origin and type, e.g. detachment due to traction, detachment without fissure or hole in retina, detachment with multiple fissures or holes in retina that occur at eyeball equator.

Противопоказания

  • Infections affecting anterior segment of the eyeball, unsuitable anatomical condition of anterior segment (microphthalmia, scars not allowing covering the circling band, allergy to silicone).

Условные противопоказания

  • Mistake during fixing the band to sclera: The eyeball might be perforated due to wrongly placed and/or tightened sutures that should fix the band to the sclera. This can happen especially in case of weakened sclera. The complication is usually asymptomatic. Bigger fissuration of the sclera should be treated by suture. The fixing suture should be repeated but at the different area. In case of bleeding, hemostyptics should be administered. When intrabulbar bleeding or impairment of retina occurs, conversion to PPV should be considered.
  • Early complications: increased intraocular pressure (usually transient), intraocular congestion of blood and intraocular hypertension resulting from compression of venae vorticosae. In such a case the surgical revision is needed. The band explantation should be considered.
  • Late complications: Dehiscence of the conjunctiva over the circling band or decubitus of the sclera that may eventually cause the eyeball perforation. Once such a complication occurs, the circling band shall be removed. Patients may feel pressure under the eyelid. Cosmetic deformation of the conjunctiva may occure. These complications depend more on the chosen surgical methodology and the surgeon’s performance, not so much on the product properties.