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Trial record 9 of 103 for:    cataract AND Astigmatism

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

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ClinicalTrials.gov Identifier: NCT02155270
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief 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.


Condition or disease Intervention/treatment Phase
Cataract Procedure: Corneal precut 600µm Procedure: Corneal stabincision Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Precut
A corneal precut of 600µm will be performed.
Procedure: Corneal precut 600µm
Active Comparator: Stab incision
A stab incision without corneal precut will be performed.
Procedure: Corneal stabincision



Primary Outcome Measures :
  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 Outcome Measures :
  1. Morphological changes over time [ Time Frame: 1 month ]


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Ages Eligible for Study:   21 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155270


Locations
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Austria
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, Austria, 1140
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
Investigators
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Principal Investigator: Oliver Findl, MD, MBA VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Prof.Dr.MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT02155270     History of Changes
Other Study ID Numbers: Precut
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Cataract
Incision
Precut
Corneal
OCT
Intraoperative OCT
Imaging
Astigmatism
Clear corneal incision

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors