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Clinical Trials/NCT01778998
NCT01778998
Completed
Not Applicable

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

Vienna Institute for Research in Ocular Surgery1 site in 1 country68 target enrollmentFebruary 2012
ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Vienna Institute for Research in Ocular Surgery
Enrollment
68
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
September 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vienna Institute for Research in Ocular Surgery
Responsible Party
Principal Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Univ.-Prof. Dr. Oliver Findl, MBA

Vienna Institute for Research in Ocular Surgery

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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