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

NCT ID: NCT03839420

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2021-02-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CZM IOL

Group Type: EXPERIMENTAL

CZM IOL

Intervention Type: DEVICE

implantation of CZM IOL

Competitor IOL

Group Type: ACTIVE_COMPARATOR

Competitor IOL

Intervention Type: DEVICE

implantation of Competitor IOL

Interventions

CZM IOL

implantation of CZM IOL

Intervention Type: DEVICE

Competitor IOL

implantation of Competitor IOL

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

929MP BER-401-18

Identifier Type: -

Identifier Source: org_study_id