EDoF IOLs vs Monofocal IOL

Cataract Clinical Trial

Official title:

Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172351
• Other study ID #: AT LARA 829MP BER-401-16
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: July 2020
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

prospective, comparative (3 arms), randomized, multicentric clinical trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• EDoF1
extended depth of focus IOL - EDoF1
• Monofocal
Monofocal IOL
• EDoF2
Comparison EDoF2 IOL

Locations

Country	Name	City	State
Germany	Zeiss Study Site	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defocus curve measurement		1 month