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

NCT01778998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-02-10

No results posted yet for this study

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

Interventions

PROCEDURE

MICS-group

Micro incision cataract surgery is done

PROCEDURE

SICS-group

small incision cataract surgery is done

PROCEDURE

SICS pre-cut

Small incision cataract surgery with pre-cut is done

PROCEDURE

SICS stab-incision

Small incision cataract surgery with stab-incision is done

Sponsors & Collaborators

  • Vienna Institute for Research in Ocular Surgery

    lead OTHER

Principal Investigators

  • Oliver Findl, MD, MBA · VIROS - Vienna Institute for Research in Ocular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778998 on ClinicalTrials.gov