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

Cataract Clinical Trial

— VENUStoric  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839420
• Other study ID #: 929MP BER-401-18
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: February 17, 2021

Study information

• Verified date: February 2023
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 17, 2021
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• CZM IOL
implantation of CZM IOL
• Competitor IOL
implantation of Competitor IOL

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL axis	IOL axis will be analyzed based on images.	Immediately after the surgery