Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
Low Asti
1 other identifier
interventional
25
1 country
1
Brief Summary
Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
April 30, 2018
CompletedStudy Start
First participant enrolled
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 2, 2019
October 1, 2019
2 years
April 30, 2018
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups
12 months
Secondary Outcomes (4)
Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)
12 months
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens
12 months
Wavefront analysis of high order aberrations (root mean square, in microns)
12 months
Questionnaire to asses patients subjective satisfaction with visual outcome
12 months
Study Arms (2)
Toric intraocular lens (IOL)
ACTIVE COMPARATORtoric intraocular lens for low astigmatism correction
Non toric intraocular lens (IOL)
SHAM COMPARATORnon toric intraocular lens
Interventions
cataract surgery with implantation of an toric intraocular lens
cataract surgery with implantation of a non toric intraocular lens
Eligibility Criteria
You may qualify if:
- cataract
- Age 21 and older
- Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D
- written informed consent prior to surgery
You may not qualify if:
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- Irregular corneal astigmatism on corneal topography
- In case of pregnancy (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 29, 2018
Study Start
May 2, 2018
Primary Completion
May 2, 2020
Study Completion
August 1, 2020
Last Updated
October 2, 2019
Record last verified: 2019-10