EDoF IOLs vs Monofocal IOL

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT03172351
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Defocus curve measurement	1 month

Trial Locations

Locations (1)

Zeiss Study Site; 🇩🇪 Freiburg, Germany