Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens (UVEA 809)

Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Suceava, Romania
    • DUO STIL SRL , Clinica Oftalmologica Medoptic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multifocal IOL; Implantation of a multifocal intraocular lens	Device: Intraocular lens; Cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular corrected distance visual acuity (CDVA)	Monocular corrected distance visual acuity measured in logMAR	6 months after the implantation

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2021
• Primary Completion (ACTUAL): August 6, 2022
• Study Completion (ACTUAL): December 16, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: LISA 809 BER-401-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No