EDoF IOLs vs Monofocal IOL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2019-04-01

Brief Summary

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

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EDoF1

Group Type EXPERIMENTAL

Monofocal

Intervention Type DEVICE

Monofocal IOL

EDoF2

Intervention Type DEVICE

Comparison EDoF2 IOL

Monofocal

Group Type ACTIVE_COMPARATOR

EDoF1

Intervention Type DEVICE

extended depth of focus IOL - EDoF1

EDoF2

Intervention Type DEVICE

Comparison EDoF2 IOL

EDoF2

Group Type ACTIVE_COMPARATOR

EDoF1

Intervention Type DEVICE

extended depth of focus IOL - EDoF1

Monofocal

Intervention Type DEVICE

Monofocal IOL

Interventions

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EDoF1

extended depth of focus IOL - EDoF1

Intervention Type DEVICE

Monofocal

Monofocal IOL

Intervention Type DEVICE

EDoF2

Comparison EDoF2 IOL

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No