EVALUATING AN INTRAOPERATIVE TORIC INTRAOCULAR LENS ALIGNMENT SYSTEM

• Research type

  Research Study

• Full title

  EVALUATION OF AN INTRA-OPERATIVE TORIC INTRAOCULAR LENS ALIGNMENT SYSTEM

• IRAS ID

  120112

• Contact name

  Say Aun Quah

• Contact email

  sayaun@lineone.net

• Sponsor organisation

  Carl Zeiss Meditec AG

• Research summary

  This controlled, randomised, prospective, non-masked study investigates the use of the CALLISTOeye intraoperative guidance system (Carl Zeiss Meditec; Jena, Germany).

  This study investigates if the CALLISTOeye device provides precise postoperative intraocular lens implant (IOL) alignment; accurate placement of any required corneal incisions; and precise positioning, size and symmetry of the capsulorhexis (the opening made into the natural lens of the eye), compared to surgery performed using a conventional surgical microscope only.

  Precise alignment and positioning of a toric IOL within the eye results in more accurate correction of astigmatism. Equally, precise positioning of any additional corneolimbal relaxing incisions (CLRI), where required, will also result in more precise correction of astigmatism. CLRIs - two arc-shaped incisions created within the layers of the corneal tissues and positioned at opposite ends of the cornea, which aim to flatten the corneal shape along the steepest corneal curve.
  Postoperative reductions in astigmatism would lead to improved visual performance and, therefore, improved participant satisfaction.

  Participants enrolled to the study will be randomly assigned to either:
  • Control Group: Toric IOL implantation guided by conventional surgical microscopy n=24
  • Study Group: Toric IOL implantation guided by a conventional surgical microscope fitted with the CALLISTOeye device n=48

  Two UK-based sites (Optegra Eye Hospitals) shall each enrol approximately 36 participants. Participants will be volunteers invited to take part by the investigators, and will be drawn from Optegra’s databases.

  This study involves assessments routinely performed before/after conventional phacoemulsification cataract surgery including:
  •Vision measurement
  •Intraocular pressure measurement
  •Pupil size measurement
  •Pupil dilation: using specialised eye drops
  •Biomicroscopic assessment of the anterior and posterior ocular tissues
  •Biomicroscopic examination of the external eye and surrounding structures
  •Ocular biometry measurements
  •Ocular anaesthesia: using local anaesthetics (drops and/or an injection)
  •Corneal marking: with a surgical marker (for example, a surgical pen)
  •Corneal incision creation: using a specialised bladed instrument
  •Examination and digital photography of the implanted toric IOL

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  13/LO/0836

• Date of REC Opinion

  24 Jun 2013

• REC opinion

  Further Information Favourable Opinion