Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)
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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 |
|---|---|
|
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery |
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 |
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 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 |
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| Contact: Oliver Findl, MD, MBA | +43 1 91021 ext 84611 | oliver@find.at |
| Austria | |
| VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital | Recruiting |
| Vienna, Austria, 1140 | |
| Contact: Oliver Findl, MD, MBA +43 1 91021 ext 84611 oliver@findl.at | |
| Sub-Investigator: Nino Hirnschall, MD | |
| Sub-Investigator: Sophie Tatzreiter, MD | |
| Sub-Investigator: Maria Weber, MD | |
| 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: | January 25, 2013 |
| 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:
|
Astigmatism Cataract Refractive Errors Eye Diseases Lens Diseases |
ClinicalTrials.gov processed this record on June 18, 2013