Back to resultsClinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses (UVEA409)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CT ASPHINA 409
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- Patients of any gender
- Assured follow-up examinations
- Biometry measurement preferably compatible with the IOLMaster evaluation;
- IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
- Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)
Exclusion Criteria:
- BCVA not available preoperatively or better than 0.3 logMAR pre-op
- 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
- Concurrent participation in another drug or device investigation -
Sites / Locations
- Department of Ophthalmology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
409M
Arm Description
CT ASPHINA 409M IOL
Outcomes
Primary Outcome Measures
Visual acuity
Monocular best corrected distance visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03145103
Brief Title
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses
Acronym
UVEA409
Official Title
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
409M
Arm Type
Experimental
Arm Description
CT ASPHINA 409M IOL
Intervention Type
Device
Intervention Name(s)
CT ASPHINA 409
Intervention Description
intraocular lens
Primary Outcome Measure Information:
Title
Visual acuity
Description
Monocular best corrected distance visual acuity
Time Frame
12 to 18 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
Patients of any gender
Assured follow-up examinations
Biometry measurement preferably compatible with the IOLMaster evaluation;
IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)
Exclusion Criteria:
BCVA not available preoperatively or better than 0.3 logMAR pre-op
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
Concurrent participation in another drug or device investigation -
Facility Information:
Facility Name
Department of Ophthalmology
City
Linköping
ZIP/Postal Code
SE58252
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32527240
Citation
Johansson B, Daniel ACS, Herbers C, Gerl M, Kretz FTA. Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study. BMC Ophthalmol. 2020 Jun 11;20(1):224. doi: 10.1186/s12886-020-01493-y.
Results Reference
derived
Learn more about this trial
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses
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