Performance of a Single-piece Toric Acrylic Intraocular Lens
Rotational Stability of a Single-piece Toric Acrylic Intraocular Lens: a Pilot Study
1 other identifier
observational
30
0 countries
N/A
Brief Summary
Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery retroillumination photographs were taken to assess the rotational stability of the IOL. Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss Meditec AG, Germany) measurements were performed at the 3 months follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2011
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
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedJune 4, 2014
June 1, 2014
1.8 years
June 12, 2013
June 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rotational stability of the investigated toric lens
Rotation of the investigated intraocular lens using a photograph technique (retroillumination images) immediately after surgery and 3 months later.
3 months
Secondary Outcomes (1)
reduction in post-operative higher order aberrations
3 months
Study Arms (1)
one group
one group receiving a toric intraocular lens during cataract surgery.
Interventions
toric intraocular lens
Eligibility Criteria
patients who were scheduled for cataract surgery and had corneal astigmatism
You may qualify if:
- corneal astigmatism between 1.0 D and 3.0 D
- cataract
You may not qualify if:
- irregular astigmatism
- forme fruste Keratoconus
- corneal scars
- phakodonesis
- pseudoexfoliation syndrome
- traumatic cataract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD, MBA
Vienna Institute for Research in Ocular Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prim. Prof. Dr., MBA
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 4, 2014
Study Start
March 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 4, 2014
Record last verified: 2014-06