Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Primary Purpose
Age Related Cataracts
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vivinex XY1
Vivinex XY1A
Sponsored by
About this trial
This is an interventional diagnostic trial for Age Related Cataracts
Eligibility Criteria
Inclusion Criteria:
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- Age 40 and older
- Astigmatism of at least 0.75Diopters in one eye
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
- Diabetes mellitus
- Pseudoexfoliation syndrome
- Systemical anticoagulation
- Antiphlogistic therapy
- Antiglaucomatosa
- Uncontrolled systemic or ocular disease
- Preceding ocular surgery or trauma
- Intraoperative complications
- Pregnancy/Nursing
- Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vivinex XY1
Vivinex XY1A
Arm Description
Implantation of an intraocular lens Hoya Vivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1A
Outcomes
Primary Outcome Measures
Number of FBGC (foreign body giant cells) (slitlamp examination)
The number of foreign body giant cells on the IOLs will be assessed.
Secondary Outcome Measures
Incidence of Monocytes (slitlamp examination)
The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2
PCO Score (slitlamp examination)
Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Grade of Anterior Fibrosis (slitlamp examination)
Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Anterior chamber reaction (slitlamp examination)
Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)
Full Information
NCT ID
NCT04230629
First Posted
January 10, 2020
Last Updated
March 8, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04230629
Brief Title
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Official Title
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.
A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vivinex XY1
Arm Type
Active Comparator
Arm Description
Implantation of an intraocular lens Hoya Vivinex XY1
Arm Title
Vivinex XY1A
Arm Type
Active Comparator
Arm Description
Implantation of an intraocular lens Hoya Vivinex XY1A
Intervention Type
Device
Intervention Name(s)
Vivinex XY1
Intervention Description
Implantation of an intraocular lens Hoya Vivinex XY1
Intervention Type
Device
Intervention Name(s)
Vivinex XY1A
Intervention Description
Implantation of an intraocular lens Hoya Vivinex XY1A
Primary Outcome Measure Information:
Title
Number of FBGC (foreign body giant cells) (slitlamp examination)
Description
The number of foreign body giant cells on the IOLs will be assessed.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Incidence of Monocytes (slitlamp examination)
Description
The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2
Time Frame
5 months
Title
PCO Score (slitlamp examination)
Description
Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Time Frame
5 months
Title
Grade of Anterior Fibrosis (slitlamp examination)
Description
Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Time Frame
5 months
Title
Anterior chamber reaction (slitlamp examination)
Description
Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
Age 40 and older
Astigmatism of at least 0.75Diopters in one eye
Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
Diabetes mellitus
Pseudoexfoliation syndrome
Systemical anticoagulation
Antiphlogistic therapy
Antiglaucomatosa
Uncontrolled systemic or ocular disease
Preceding ocular surgery or trauma
Intraoperative complications
Pregnancy/Nursing
Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupert Menapace
Phone
0140400
Ext
66300
Email
rupert.menapace@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
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