- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369482
Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL (Clarinex)
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna Allgemeines Krankenhaus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 50 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
- Preceding intraocular surgery or ocular trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
- Laser treatment
- Uncontrolled systemic or ocular disease
- Infectious disease
- Pregnancy/Nursing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alcon Clareon
Implantation of an intraocular lens Alcon Clareon
|
Implantation of an intraocular lens Hoya Vivinex
|
Active Comparator: Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex
|
Implantation of an intraocular lens Alcon Clareon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCO score
Time Frame: 3 years
|
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: 3 years
|
UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
|
3 years
|
Fibrosis
Time Frame: 3 years
|
grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
|
3 years
|
Subjective glistening score
Time Frame: 3 years
|
neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
|
3 years
|
YAG capsulotomy rate
Time Frame: 3 years
|
described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clarinex 1560/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Age Related Cataracts
-
Medical University of ViennaRecruiting
-
Sun Yat-sen UniversityUnknown
-
Medical University of ViennaNot yet recruiting
-
Medical University of ViennaCompleted
-
Rupert MenapaceUnknownAge Related CataractsAustria
-
Medical University of ViennaCompleted
-
Medical University of ViennaRecruitingAstigmatism | Age Related CataractsAustria
-
Medical University of ViennaRecruitingAstigmatism | Age Related CataractsAustria
-
Livionex Inc.Completed
-
Medical University of ViennaUnknownAge Related Cataracts | Cystoid Macular EdemaAustria
Clinical Trials on Hoya Vivinex
-
Medical University of ViennaCompleted
-
Vastra Gotaland RegionCompletedInflammation | Uveitis | Cataract | Posterior Capsule OpacificationSweden
-
Medical University of ViennaNot yet recruiting
-
Hoya Surgical Optics, Inc.CompletedCataract | AphakiaAustralia
-
Innovative MedicalUnknownCataractsUnited States
-
Medical University of ViennaCompletedCataract | Posterior Capsule OpacificationAustria
-
The S.N. Fyodorov Eye Microsurgery State InstitutionAlcon ResearchRecruitingCorneal Astigmatism | Cataract Senile | Myopia, High-GradeRussian Federation
-
Medical University of ViennaCompletedCataract | Posterior Capsule OpacificationAustria
-
Hoya Surgical Optics, Inc.CompletedAphakiaUnited States