Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study
Condition: Cataract
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and
      surgically induced astigmatism as compared to a stab-incision (a corneal incision without a
      pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.

      Postoperatively, OCT scans will be obtained, corneal curvature will be measured and
      subjective and objective refraction will be performed in order to measure the
      surgically-induced astigmatism.
    

Detailed description: 
      Corneal wound architecture in cataract surgery has recently been assessed1-4 using optical
      coherence tomography. However, none of these studies observed the effect of the wound
      architecture on postoperative astigmatism. In a previous study performed at our center,
      cataract surgery using a 1.8 mm micro incision (MICS) was compared to a 2.5 mm standard
      incision (SICS) regarding wound architecture and surgically induced astigmatism. Wound size
      and wound architecture were assessed using a Time-Domain OCT intraand postoperatively. After
      implantation of the IOL the incisions were shown to be larger than planned.

      This effect was shown to be more pronounced in the small incision group. Both epithelial and
      endothelial wound gaping at the end of surgery occurred more often in the MICS group.
      Furthermore, this study showed no effect of a 300 μm pre-cut on postoperative wound
      architecture and surgically induced astigmatism. Based on these findings we would like to
      perform another study using a high-resolution Spectral-Domain OCT, which allows for a
      three-dimensional depiction of wound architecture and a better understanding of the dynamic
      changes in wound structure during surgery. Furthermore a new high resolution OCT device will
      be available outside the operating theatre for postoperative measurements. Both devices are
      CE certified, will be used according to their indication and allow noncontact and therefore
      pain free measurements. As no significant impact of a 300μm pre-cut on wound architecture and
      astigmatism was shown in the predecessor study, we would like to evaluate the use of a 600μm
      pre-cut regarding wound architecture and surgically induced astigmatism as compared to a
      stab-incision (a corneal incision without a pre-cut). A dedicated wound architecture score
      will be used to evaluate wound configuration.

      Postoperatively, OCT scans will be obtained, corneal curvature will be measured and
      subjective and objective refraction will be performed in order to measure the
      surgically-induced astigmatism.
    

Intervention name(s): Corneal precut 600µm; Corneal stabincision
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cataract; Incision; Precut; Corneal; OCT; Intraoperative OCT; Imaging; Astigmatism; Clear corneal incision