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

Cataract Clinical Trial

— INCISIONS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778998
• Other study ID #: INCISIONS
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: February 7, 2014
• Start date: February 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2014
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: BASG/AGES
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Procedure:
• MICS-group
Micro incision cataract surgery is done
• SICS-group
small incision cataract surgery is done
• SICS pre-cut
Small incision cataract surgery with pre-cut is done
• SICS stab-incision
Small incision cataract surgery with stab-incision is done

Locations

Country	Name	City	State
Austria	VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		pre-operatively to one day post-operativly	No