Low-add Multifocal vs. Monofocal IOLs
Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
Compare low-add multifocal IOLs with monofocal IOLs to evaluate if patients in the low-add multifocal IOL group have better unaided distance visual acuity compared to the monofocal group.
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 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
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 21, 2018
November 1, 2018
1.7 years
November 19, 2018
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spectacle independence questionnaire
Spectacle independence will be assessed using a questionnaire. In this questionnaire the patient will be asked about usage of spectacles for far, near and intermediate distance. Best result will be if the patient is independent from any spectacles in the different distances.
12 months
Secondary Outcomes (2)
Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity
12 months
Titmus Fly Stereo test
12 months
Study Arms (2)
Lentis comfort
EXPERIMENTALPatient will receive the low-add multifocal IOL during cataract surgery
Lentis L-313
EXPERIMENTALPatient will receive the monofocal IOL Lentis L-313 during cataract surgery
Interventions
Eligibility Criteria
You may qualify if:
- Age-related cataract in both eyes
- Scheduled for bilateral cataract surgery
- Motivated to be less spectacle dependant in the distance to intermediate vision range
- Patients with an expected BCDVA of 0.8 snellen score or better after surgery
- Patients with the need of an IOL Power in the range of 10 to 30D (biometry performed with the IOL master 700)
- Age 21 and older
- Written informed consent prior to recruitment
You may not qualify if:
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Retinopathia pigmentosa
- Chronic uveitis
- Amblyopia
- Pupil decentration \> 1mm center shift
- preceded retinal surgery
- preceded Laser-in-situ-Keratomileusis (LASIK)
- Any ophthalmic abnormality that could compromise visual function or the measurements
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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
April 1, 2018
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
November 21, 2018
Record last verified: 2018-11