Rotational Stability of the TECNIS Eyhance Toric
1 other identifier
interventional
50
1 country
1
Brief Summary
Evaluation of the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance toric II.
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 Apr 2021
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
April 29, 2021
CompletedFirst Submitted
Initial submission to the registry
November 2, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2022
CompletedNovember 19, 2021
November 1, 2021
1 year
November 2, 2021
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rotational stability
The change in the intraocular lens axis (given in degrees) of the Eyhance toric IOL of one eye will be analysed by taking photographs of the IOL and will be compared between the different study time points.
12 months
Secondary Outcomes (1)
Distance visual acuity
12 months
Study Arms (1)
Eyhance toric II
EXPERIMENTALThe Eyhance toric II intraocular lens will be implanted in one of the patients eyes during cataract surgery
Interventions
During cataract surgery the Eyhance toric II intraocular lens will be implanted in one eye of the patient
Eligibility Criteria
You may qualify if:
- Cataract
- Age 21 and older
- Regular corneal astigmatism \> 0.75 dioptres
- Written informed consent prior to surgery
You may not qualify if:
- Relevant other ophthalmic diseases such as pseudoexfoliation, traumatic cataract, corneal scars or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)
- High myopia (\> 29 mm AL)
- Irregular corneal astigmatism on corneal topography
- Pregnancy (a pregnancy test will be taken preoperatively in women of reproductive age)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140, Austria
Related Publications (1)
Zeilinger J, Hienert J, Ruiss M, Pilwachs C, Findl O. Rotational stability of a new toric intraocular lens with an advanced optical profile. J Cataract Refract Surg. 2023 Jun 1;49(6):584-588. doi: 10.1097/j.jcrs.0000000000001158.
PMID: 36745852DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD
Vienna Institute for Research in Ocular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2021
First Posted
November 19, 2021
Study Start
April 29, 2021
Primary Completion
April 29, 2022
Study Completion
November 29, 2022
Last Updated
November 19, 2021
Record last verified: 2021-11