To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses (VENUStoric)

Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: CZM IOL; Device: Competitor IOL

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Estelle Poineau; Phone Number: 0546523154; Email: estelle.poineau@zeiss.com

Study Locations

• Germany
  • Freiburg, Germany
    • Universitätsklinikum Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
2. Patients of any gender, aged 18 or older
3. Assured follow-up examinations
4. Healthy eyes with clinically significant age related cataract requiring surgical treatment
5. Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
6. Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)

8. Cataract density compatible with biometry measurement

Exclusion Criteria:

1. Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
2. Patients whose freedom is impaired by administrative or legal order
3. Current participation in another drug or device investigation that affects patients vision
4. Ocular disorders, other than cataract, that could potentially cause future acuity loss
5. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
6. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
7. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
8. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
9. 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
10. Pseudoexfoliation syndrome (according to investigator decision)
11. Pathologic miosis or Pharmacotherapy with miotic agent
12. Irregular astigmatism / Keratoconus
13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
14. All kind of infections (acute ocular disease, external / internal infection, systemic infection)
15. Traumatic cataract
16. Monophthalmic patient
17. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
18. Patient expected to require retinal laser treatment before the end of the last follow-up examination
19. Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
20. Previous intraocular and corneal / refractive surgery
21. Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
22. Dementia
23. Previous use of cytotoxic drugs or total body irradiation within last 2 years
24. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
25. Pregnancy and / or lactation period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CZM IOL	Device: CZM IOL; implantation of CZM IOL
ACTIVE_COMPARATOR: Competitor IOL	Device: Competitor IOL; implantation of Competitor IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOL axis	IOL axis will be analyzed based on images.	Immediately after the surgery

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ACTUAL): October 4, 2020
• Study Completion (ACTUAL): February 17, 2021

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 929MP BER-401-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No