To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses

NCT03839420 | Completed

• 1 other identifier: 929MP BER-401-18
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• IOL axis

  IOL axis will be analyzed based on images.

  Immediately after the surgery

Study Arms (2)

CZM IOL

EXPERIMENTAL

Device: CZM IOL

Competitor IOL

ACTIVE COMPARATOR

Device: Competitor IOL

Interventions

CZM IOL DEVICE

implantation of CZM IOL

CZM IOL

Competitor IOL DEVICE

implantation of Competitor IOL

Competitor IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 18 or older
• Assured follow-up examinations
• Healthy eyes with clinically significant age related cataract requiring surgical treatment
• Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
• Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
• \. Cataract density compatible with biometry measurement

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 that affects patients vision
• Ocular disorders, other than cataract, that could potentially cause future acuity loss
• Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
• Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
• Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
• Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
• History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
• Pseudoexfoliation syndrome (according to investigator decision)
• Pathologic miosis or Pharmacotherapy with miotic agent
• Irregular astigmatism / Keratoconus
• Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
• All kind of infections (acute ocular disease, external / internal infection, systemic infection)
• Traumatic cataract

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: comparative randomized trial

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 15, 2019
• Study Start: July 8, 2019
• Primary Completion: October 4, 2020
• Study Completion: February 17, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)