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

NCT01778998 | Completed DMC

• 1 other identifier: INCISIONS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Cataract

Keywords

incision; pre-cut; wound architecture; OCT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

MICS-group

ACTIVE COMPARATOR

Procedure: MICS-group

SICS-group

ACTIVE COMPARATOR

Procedure: SICS-group

SICS pre-cut

ACTIVE COMPARATOR

Procedure: SICS pre-cut

SICS stab-incision

ACTIVE COMPARATOR

Procedure: SICS stab-incision

Interventions

MICS-group PROCEDURE

Micro incision cataract surgery is done

MICS-group

SICS-group PROCEDURE

small incision cataract surgery is done

SICS-group

SICS pre-cut PROCEDURE

Small incision cataract surgery with pre-cut is done

SICS pre-cut

SICS stab-incision PROCEDURE

Small incision cataract surgery with stab-incision is done

SICS stab-incision

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-related cataract
• Age 21 and older
• written informed consent prior to recruitment

You may not qualify if:

• Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
• Any ophthalmic abnormality that could compromise the measurements

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract; Surgical Wound

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• Oliver Findl, MD, MBA

  VIROS - Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Univ.-Prof. Dr. Oliver Findl, MBA

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

AU (1)