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Completed

NCT Number: NCT02155270

Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot 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.

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Key information

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age-related cataract
  • Age 21 and older
  • written informed consent prior to recruitment

Exclusion criteria

  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
  • Any ophthalmic abnormality that could compromise the measurements

Treatment and study plan

Corneal precut 600µm

Procedure

Corneal stabincision

Procedure

Primary outcomes

  1. Correlation between a wound architecture score and the post-operative astigmatism for the "pre-cut" group and the "stab-incision" group

    Time frame: 1 month

Secondary outcomes

  1. Morphological changes over time

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2014
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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