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

• Sponsor: Carl Zeiss Meditec AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03839420
• Collaborator: (none)
• Enrollment: 318
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: CZM IOL; Device: Competitor IOL	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 318 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: comparative randomized trialcomparative randomized trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
• Actual Study Start Date: Jul 8, 2019
• Actual Primary Completion Date: Oct 4, 2020
• Anticipated Study Completion Date: Feb 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CZM IOL	Device: CZM IOL; implantation of CZM IOL
Active Comparator: Competitor IOL	Device: Competitor IOL; implantation of Competitor IOL

Outcome Measures

Primary Outcome Measures

1. IOL axis [Immediately after the surgery]

   IOL axis will be analyzed based on images.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

7. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Freiburg	Freiburg		Germany

Sponsors and Collaborators

• Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carl Zeiss Meditec AG
• ClinicalTrials.gov Identifier: NCT03839420
• Other Study ID Numbers: 929MP BER-401-18
• First Posted: Feb 15, 2019
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jan 27, 2021