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Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Corneal precut 600µm
Corneal stabincision
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract focused on measuring Cataract, Incision, Precut, Corneal, OCT, Intraoperative OCT, Imaging, Astigmatism, Clear corneal incision

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Type

Active Comparator

Active Comparator

Arm Label

Precut

Stab incision

Arm Description

A corneal precut of 600µm will be performed.

A stab incision without corneal precut will be performed.

Outcomes

Primary Outcome Measures

Correlation between a wound architecture score and the post-operative astigmatism for the "pre-cut" group and the "stab-incision" group

Secondary Outcome Measures

Morphological changes over time

Full Information

First Posted
June 2, 2014
Last Updated
February 9, 2017
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT02155270
Brief Title
Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study
Official Title
Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration. Postoperatively, OCT scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.
Detailed Description
Corneal wound architecture in cataract surgery has recently been assessed1-4 using optical coherence tomography. However, none of these studies observed the effect of the wound architecture on postoperative astigmatism. In a previous study performed at our center, cataract surgery using a 1.8 mm micro incision (MICS) was compared to a 2.5 mm standard incision (SICS) regarding wound architecture and surgically induced astigmatism. Wound size and wound architecture were assessed using a Time-Domain OCT intraand postoperatively. After implantation of the IOL the incisions were shown to be larger than planned. This effect was shown to be more pronounced in the small incision group. Both epithelial and endothelial wound gaping at the end of surgery occurred more often in the MICS group. Furthermore, this study showed no effect of a 300 μm pre-cut on postoperative wound architecture and surgically induced astigmatism. Based on these findings we would like to perform another study using a high-resolution Spectral-Domain OCT, which allows for a three-dimensional depiction of wound architecture and a better understanding of the dynamic changes in wound structure during surgery. Furthermore a new high resolution OCT device will be available outside the operating theatre for postoperative measurements. Both devices are CE certified, will be used according to their indication and allow noncontact and therefore pain free measurements. As no significant impact of a 300μm pre-cut on wound architecture and astigmatism was shown in the predecessor study, we would like to evaluate the use of a 600μm pre-cut regarding wound architecture and surgically induced astigmatism as compared to a stab-incision (a corneal incision without a pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration. Postoperatively, OCT scans will be obtained, corneal curvature will be measured and subjective and objective refraction will be performed in order to measure the surgically-induced astigmatism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Incision, Precut, Corneal, OCT, Intraoperative OCT, Imaging, Astigmatism, Clear corneal incision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precut
Arm Type
Active Comparator
Arm Description
A corneal precut of 600µm will be performed.
Arm Title
Stab incision
Arm Type
Active Comparator
Arm Description
A stab incision without corneal precut will be performed.
Intervention Type
Procedure
Intervention Name(s)
Corneal precut 600µm
Intervention Type
Procedure
Intervention Name(s)
Corneal stabincision
Primary Outcome Measure Information:
Title
Correlation between a wound architecture score and the post-operative astigmatism for the "pre-cut" group and the "stab-incision" group
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Morphological changes over time
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 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 Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
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

Citations:
PubMed Identifier
33709325
Citation
Doeller B, Hirnschall N, Fichtenbaum M, Nguyen PM, Varsits R, Findl O. A Randomized Study of the Impact of a Corneal Pre-Cut During Cataract Surgery on Wound Architecture and Corneal Astigmatism. Ophthalmol Ther. 2021 Jun;10(2):313-320. doi: 10.1007/s40123-021-00339-0. Epub 2021 Mar 11.
Results Reference
derived

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Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study

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