Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

NCT ID: NCT04907500

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2022-12-16

Brief Summary

Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

Detailed Description

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.

Conditions

Cataract Senile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multifocal IOL

Implantation of a multifocal intraocular lens

Group Type: EXPERIMENTAL

Intraocular lens

Intervention Type: DEVICE

Cataract surgery

Interventions

Intraocular lens

Cataract surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients of any gender, aged 18 years or older

2. Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye

3. Patient is willing and capable of providing informed consent

4. Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria

1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)

2. Endothelial cell count of less than 2000/mm2

3. Ocular disorder that could potentially cause a clinically significant future visual acuity loss

4. Preoperative corneal astigmatism ative corneal to be < 1 D.

5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)

6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)

7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)

8. Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis

9. Any acute infection (acute ocular disease, external/internal infection, systemic infection)

10. Any previous intraocular and corneal surgery

11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment

12. Current systemic or ocular pharmacotherapy that effects patients'vision

13. Current pathology or condition that could be a risk for the patient according to the investigator opinion

14. Women during pregnancy and/or lactation

15. Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial

16. Patients whose freedom is impaired by administrative or legal order

17. Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision

• 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

DUO STIL SRL , Clinica Oftalmologica Medoptic

Suceava, , Romania

Countries

Romania

Other Identifiers

LISA 809 BER-401-20

Identifier Type: -

Identifier Source: org_study_id