Impact of a Corneal Pre-cut on Wound Architecture and Astigmatism in Cataract Surgery - a Pilot Study
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 13, 2017
February 1, 2017
1.2 years
June 2, 2014
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between a wound architecture score and the post-operative astigmatism for the "pre-cut" group and the "stab-incision" group
1 month
Secondary Outcomes (1)
Morphological changes over time
1 month
Study Arms (2)
Precut
ACTIVE COMPARATORA corneal precut of 600µm will be performed.
Stab incision
ACTIVE COMPARATORA stab incision without corneal precut will be performed.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, 1140, Austria
Related Publications (1)
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.
PMID: 33709325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD, MBA
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof.Dr.MBA
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 4, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
February 13, 2017
Record last verified: 2017-02