EDoF IOLs vs Monofocal IOL
Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
1 other identifier
interventional
216
1 country
1
Brief Summary
prospective, comparative (3 arms), randomized, multicentric clinical trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJuly 16, 2020
July 1, 2020
1.6 years
May 24, 2017
July 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Defocus curve measurement
1 month
Study Arms (3)
EDoF1
EXPERIMENTALMonofocal
ACTIVE COMPARATOREDoF2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;
- Patients of any gender, aged 50 to 80 years;
- Assured follow-up examinations;
- clinically significant bilateral cataract;
You may not qualify if:
- Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;
- Patients whose freedom is impaired by administrative or legal order;
- Current participation in another drug or device investigation;
- Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- Pseudoexfoliations syndrome
- Pathologic miosis or Pharmacotherapy with miotic agent
- Keratoconus
- Chronic or recurrent uveitis
- Diabetic retinopathy
- Uncontrolled glaucoma and or IOP\>24mmHg
- Choroidal hemorrhage,
- All kind of infections (acute ocular disease, external/internal infection, systemic infection)
- Traumatic cataract
- Aniridia
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeiss Study Site
Freiburg im Breisgau, Germany
Related Publications (1)
Reinhard T, Maier P, Bohringer D, Bertelmann E, Brockmann T, Kiraly L, Salom D, Piovella M, Colonval S, Mendicute J. Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):431-442. doi: 10.1007/s00417-020-04868-5. Epub 2020 Sep 11.
PMID: 32915276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2017
First Posted
June 1, 2017
Study Start
May 24, 2017
Primary Completion
January 1, 2019
Study Completion
April 1, 2019
Last Updated
July 16, 2020
Record last verified: 2020-07