Prospective randomized clinical trial comparing early rotation of two extended depth of focus intraocular lenses
- Conditions
- cataract
- Registration Number
- DRKS00027025
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 153
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 45 or older
3. Assured follow-up examinations
4. Eyes with clinically significant age related cataract requiring surgical treatment, otherwise healthy
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. Calculated IOL power is within SE +14.0 D and +30.0 D (in 0.5 diopter increments) and between a cylindrical range of +1.0 D to +4.0 D, in the study eye(s).
7. Uni- and/or bilaterally regular corneal astigmatism confirmed by topography measurement
8. Cataract density compatible with biometry measurement
9. In case both eyes will be included, patient agreed to have surgery of the second eye performed between 1 day and 1 month after the surgery of the first eye.
10. Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
11. Patients whose freedom is impaired by administrative or legal order
12. Current systemic or ocular pharmacotherapy that may interfere with the conductance of the trial in the opinion of the investigator. (e.g. Chloroquine and Hydroxychloroquine (Maculopathy), Tamoxifen (Retinopathy), Ethambutol (Optic Neuropathy)
13. Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
14. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
15. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
16. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
17. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
18. 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
19. Pseudoexfoliation syndrome (according to investigator decision)
20. Pathologic miosis or Pharmacotherapy with miotic agent
21. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
22. All kind of infections (acute ocular disease, external / internal infection, systemic infection)
23. Traumatic cataract
24. Monophthalmic patient
25. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
26. Patient expected to require retinal laser treatment before the end of the last follow-up examination
27. Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
28. Previous intraocular and corneal / refractive surgery
29. Dementia
30. Previous use of cytotoxic drugs or total body irradiation within last 2 years
31. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
32. Pregnancy and / or lactation period
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IOL rotation up to 6 months after the surgery
- Secondary Outcome Measures
Name Time Method Rotational stability up to 6 months after implantation;<br>Visual acuity and refraction at 1 and 6 months after the surgery; general safety