Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens (UVEA 809)
Primary Purpose
Cataract Senile
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Senile
Eligibility Criteria
Inclusion Criteria:
- Patients of any gender, aged 18 years or older
- Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
- Patient is willing and capable of providing informed consent
- Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion Criteria:
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Ocular disorder that could potentially cause a clinically significant future visual acuity loss
- Preoperative corneal astigmatism ative corneal to be < 1 D.
- Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- 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
- Any acute infection (acute ocular disease, external/internal infection, systemic infection)
- Any previous intraocular and corneal surgery
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- Current systemic or ocular pharmacotherapy that effects patients'vision
- Current pathology or condition that could be a risk for the patient according to the investigator opinion
- Women during pregnancy and/or lactation
- Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- 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
Sites / Locations
- DUO STIL SRL , Clinica Oftalmologica Medoptic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multifocal IOL
Arm Description
Implantation of a multifocal intraocular lens
Outcomes
Primary Outcome Measures
Monocular corrected distance visual acuity (CDVA)
Monocular corrected distance visual acuity measured in logMAR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04907500
Brief Title
Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens
Acronym
UVEA 809
Official Title
Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
August 6, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal IOL
Arm Type
Experimental
Arm Description
Implantation of a multifocal intraocular lens
Intervention Type
Device
Intervention Name(s)
Intraocular lens
Intervention Description
Cataract surgery
Primary Outcome Measure Information:
Title
Monocular corrected distance visual acuity (CDVA)
Description
Monocular corrected distance visual acuity measured in logMAR
Time Frame
6 months after the implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of any gender, aged 18 years or older
Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
Patient is willing and capable of providing informed consent
Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion Criteria:
Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
Endothelial cell count of less than 2000/mm2
Ocular disorder that could potentially cause a clinically significant future visual acuity loss
Preoperative corneal astigmatism ative corneal to be < 1 D.
Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
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
Any acute infection (acute ocular disease, external/internal infection, systemic infection)
Any previous intraocular and corneal surgery
Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
Current systemic or ocular pharmacotherapy that effects patients'vision
Current pathology or condition that could be a risk for the patient according to the investigator opinion
Women during pregnancy and/or lactation
Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
Patients whose freedom is impaired by administrative or legal order
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
Facility Information:
Facility Name
DUO STIL SRL , Clinica Oftalmologica Medoptic
City
Suceava
Country
Romania
12. IPD Sharing Statement
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Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens
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