Rotational Stability Analysis of a Toric Monofocal IOL
PHY2013
Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
1 other identifier
interventional
23
1 country
1
Brief Summary
This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.
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 Aug 2014
Longer than P75 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
Study Start
First participant enrolled
August 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedJune 21, 2021
June 1, 2021
1.4 years
June 18, 2021
June 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability.
3 months postoperative
Secondary Outcomes (1)
Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery
Study Arms (1)
Ankoris IOL Implantation experimental
EXPERIMENTALMonolateral implantation of toric intraocular lenses Ankoris
Interventions
Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).
Eligibility Criteria
You may qualify if:
- Cataracteous Eyes with no comorbidity
- Regular corneal astigmatism \>1 dioptre and \<3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent •\>50 years old
You may not qualify if:
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beaver-Visitec International, Inc.lead
- targomedGmbHcollaborator
Study Sites (1)
Ruhr-Universitat Bochum, Bochum, Germany
Bochum, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Burkhard Dick, MD
Ruhr-Universitat Bochum, Bochum, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 21, 2021
Study Start
August 26, 2014
Primary Completion
January 1, 2016
Study Completion
March 1, 2019
Last Updated
June 21, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share