SAMBUCA version1

• Research type

  Research Study

• Full title

  SAMBUCA – Study of Adjuvant Macular BUCkling for Myopic Foveoschisis with high Axial length.

• IRAS ID

  211790

• Contact name

  Lyndon da Cruz

• Sponsor organisation

  Moorfields Eye Hospital NHS Foundation Trust

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Myopia is the medical term for short-sightedness. In very short-sighted people, the outer coat of the eye (the sclera) can form an outpouching at the back surface of the eye, known as a posterior staphyloma. This in turn is associated with a number of conditions such as splitting of the central retina (myopic foveoschisis), detachment of the central retina (foveal detachment), or even formation of a hole in the central retina (myopic macular hole) which in turn can lead to detachment of the entire retina. All of these conditions can impair vision.

  Current surgical treatments for diseases of the central retina, known as the macula, involve a procedure called pars plana vitrectomy. This is a widely performed operation (>20,000 in the UK in 2013-2014) with a good safety profile but it has been postulated that although vitrectomy is useful for many macular disorders, it may be insufficient to treat highly myopic eyes, because it does not address the underlying structural change caused by the staphyloma. Some surgeons advocate the use of a “macular buckle”, a piece of silicone that is sutured to the outside of the eye and which causes the back of the eye to be indented, thereby pushing the staphyloma closer to the centre of the eye. Macular buckling has been performed in Japan, Spain and several other countries, with excellent surgical results and improvements in vision.

  Although buckles are widely used in the UK for the treatment of retinal detachment due to peripheral retinal holes, in the UK buckles are not commonly for diseases of the central retina. This is partly because it is uncertain whether buckling in addition to vitrectomy surgery yields better visual outcomes. Furthermore, there is no CE-marked macular buckle available in the UK. This study proposes the use of combined macular buckling and vitrectomy in 10 patients with myopic staphyloma-associated disease.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  17/LO/0668

• Date of REC Opinion

  9 Apr 2018

• REC opinion

  Further Information Favourable Opinion