- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789538
Safety and Effectiveness of an Hydrophilic Acrylic Intraocular Lens
May 4, 2022 updated by: Carl Zeiss Meditec AG
Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens (509)
Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens
Study Overview
Detailed Description
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.
Study Type
Observational
Enrollment (Actual)
328
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69275
- Hôpital Desgenettes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients implanted with the study lens IOLs
Description
Inclusion Criteria:
- Patients of any gender, aged 18 years or older at the time of the surgery
- Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
- Currently implanted with the study device into the capsular bag in at least one eye
- One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
- 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) or CDVA not available preoperatively
- Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
- Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
- Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- Any preoperative documented 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 preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
- Any previous preoperative intraocular and corneal surgery
- Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
- Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
- Women during pregnancy and/or lactation at time of enrollment into the study
- Patients unable to meet the limitations of the protocol or likely of non-cooperation 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Monofocal IOL
|
not applicable as patients are already implanted with the monofocal intraocular lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 12 to 24 months after the implantation
|
Visual acuity at far distance
|
12 to 24 months after the implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2021
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASPHINA 509 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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