Clinical trial NCT03172351: EDoF IOLs vs Monofocal IOL
Official title: Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 216
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: prospective, comparative (3 arms), randomized, multicentric clinical trial


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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
* Microphthalmia
* Amblyopia
* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
* Previous intraocular and corneal surgery
* Expected postop. astigmatism greater than 1 D
* Any type of corneal disorder
* Systemic or ocular pharmacotherapy, which can impact the visual acuity,
* Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
* Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
* Dementia
* pregnancy or lactation period for female patients

Primary outcomes:
measure: Defocus curve measurement
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Zeiss Study Site
Study officials:
References:
citation: 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.