Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT01778998
First received: January 25, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

One of the most recent advances in cataract surgery is microincisional phacoemulsification (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either bimanually or with a thin single coaxial hand-piece. The possible advantages are lower induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher resistance of the wound to deformation3 and a lower risk of complications such as iris prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome (IFIS). Additional factors that have to be taken into account are the construction and the position of the incision and the influence of the extraocular force on the wound morphology.4 Another effect that may influence the wound architecture is stromal hydration at the end of surgery.5 Wound architecture has recently been assessed6-9 using optical coherence tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing on corneal thickness and the incision angle. However, none of these studies observed the effect of the wound architecture on post-operative astigmatism. Furthermore, all observations in the past have been performed in the post-operative period only and information concerning the wound architecture intra-operatively is missing. A recently launched CE-marked intra-operative OCT allows observing the wound architecture intra-operatively.

One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line


Condition Intervention
Cataract
Procedure: MICS-group
Procedure: SICS-group
Procedure: SICS pre-cut
Procedure: SICS stab-incision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study

Resource links provided by NLM:


Further study details as provided by Vienna Institute for Research in Ocular Surgery:

Primary Outcome Measures:
  • o Correlation between a wound architecture score (developed during the study) and the post-operative astigmatism for the "MICS", the "SICS", the "SICS pre-cut" and the "SICS stab-incision" group [ Time Frame: pre-operatively to one day post-operativly ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MICS-group Procedure: MICS-group
Micro incision cataract surgery is done
Active Comparator: SICS-group Procedure: SICS-group
small incision cataract surgery is done
Active Comparator: SICS pre-cut Procedure: SICS pre-cut
Small incision cataract surgery with pre-cut is done
Active Comparator: SICS stab-incision Procedure: SICS stab-incision
Small incision cataract surgery with stab-incision is done

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01778998

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

No publications provided

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Prim. Univ.-Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT01778998     History of Changes
Other Study ID Numbers: INCISIONS
Study First Received: January 25, 2013
Last Updated: February 7, 2014
Health Authority: Austria: BASG/AGES

Keywords provided by Vienna Institute for Research in Ocular Surgery:
incision
pre-cut
wound architecture
OCT

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

ClinicalTrials.gov processed this record on September 18, 2014