Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MICS-group
SICS-group
SICS pre-cut
SICS stab-incision
Sponsored by
About this trial
This is an interventional basic science trial for Cataract focused on measuring incision, pre-cut, wound architecture, OCT
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
Sites / Locations
- VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
MICS-group
SICS-group
SICS pre-cut
SICS stab-incision
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01778998
First Posted
January 25, 2013
Last Updated
February 7, 2014
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT01778998
Brief Title
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study
Acronym
INCISIONS
Official Title
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
incision, pre-cut, wound architecture, OCT
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MICS-group
Arm Type
Active Comparator
Arm Title
SICS-group
Arm Type
Active Comparator
Arm Title
SICS pre-cut
Arm Type
Active Comparator
Arm Title
SICS stab-incision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
MICS-group
Intervention Description
Micro incision cataract surgery is done
Intervention Type
Procedure
Intervention Name(s)
SICS-group
Intervention Description
small incision cataract surgery is done
Intervention Type
Procedure
Intervention Name(s)
SICS pre-cut
Intervention Description
Small incision cataract surgery with pre-cut is done
Intervention Type
Procedure
Intervention Name(s)
SICS stab-incision
Intervention Description
Small incision cataract surgery with stab-incision is done
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA
Organizational Affiliation
VIROS - Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
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Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study
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