Clinical trial NCT03839420: To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Official title: Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative randomized trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: IOL axis
timeFrame: Immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
Study officials:
References: