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UVEA 809: Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04907500
Collaborator
(none)
352
Enrollment
1
Location
1
Arm
18.3
Anticipated Duration (Months)
19.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Intraocular lens
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
352 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
Actual Study Start Date :
Jun 22, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multifocal IOL

Implantation of a multifocal intraocular lens

Device: Intraocular lens
Cataract surgery

Outcome Measures

Primary Outcome Measures

  1. Monocular corrected distance visual acuity (CDVA) [6 months after the implantation]

    Monocular corrected distance visual acuity measured in logMAR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 DUO STIL SRL , Clinica Oftalmologica Medoptic Suceava Romania

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT04907500
Other Study ID Numbers:
  • LISA 809 BER-401-20
First Posted:
May 28, 2021
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Aug 3, 2021