Anterior Chamber Depth Variability Between Two Lenses With Different Materials
Anterior Chamber Depth (ACD) Variability Between the Clareon and Acrysof IOL: a Randomised Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and the AcrySof Intraocular lens (IOL) after implantation over 6 months.
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 Oct 2018
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
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 19, 2019
April 1, 2019
1.2 years
November 20, 2018
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anterior chamber depth (ACD)
The change in anterior chamber depth (ACD) before and after cataract surgery will be measured using the IOL Master 700 and compared between the two different IOLs.
12 months
Secondary Outcomes (1)
Distance visual acuity
12 months
Study Arms (1)
Monofocal IOL
EXPERIMENTALPatients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery
Interventions
During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye
Eligibility Criteria
You may qualify if:
- Age-related cataract in both eyes
- Scheduled for bilateral cataract surgery
- Age 21 and older
- Written informed consent prior to recruitment
- Visual Acuity \> 0.05
You may not qualify if:
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Any ophthalmic abnormality that could compromise visual function or the measurements
- Presence of potential zonular weakness such as pseudoexfoliation Syndrome, history of ocular trauma, previous ocular surgery.
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)
Ullrich M, Ruiss M, Hienert J, Pilwachs C, Fisus AD, Georgiev S, Hirnschall N, Findl O. Anterior chamber depth variability between 2 hydrophobic acrylic 1-piece intraocular lenses: randomized trial. J Cataract Refract Surg. 2021 Nov 1;47(11):1460-1465. doi: 10.1097/j.jcrs.0000000000000668.
PMID: 33929807DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 23, 2018
Study Start
October 1, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 19, 2019
Record last verified: 2019-04