Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector: Visual Outcomes, Refractive Stability, Safety Features, YAG Capsulotomy Rate. (Retrospective Review)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Primary objective
Study Overview
Brief Summary
The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).
Detailed Description
The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).
- Primary objective:
o To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation
-
Secondary objectives:
-
To evaluate the spherical equivalent refraction one month postoperatively.
-
To evaluate level of astigmatism one month postoperatively.
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To evaluate the Uncorrected Distance Visual Acuity (UDVA) monocular at 1 day, 1 month and 6 months after IOL implantation
-
To evaluate the Best Corrected Distance Visual Acuity (CDVA) monocular at 1 month, 6 months and 1 year after IOL implantation
-
To evaluate safety features of the lens
-
To evaluate PCO development, Nd:YAG capsulotomy rate
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients who underwent cataract surgery in one or both eyes and who were implanted with Bi-Flex 877PAY IOL mono- or bilaterally.
- •Patients with regular post-operative visits over 12 months period after surgery.
- •Patients of any age above 18 years and any medical history who are eligible according the investigator's decision.
Exclusion Criteria
- •preoperative corneal astigmatism > 1.5 D
- •uncontrolled diabetic retinopathy
- •iris neovascularisation
- •serious intraoperative complications
Outcomes
Primary Outcomes
Primary objective
Time Frame: 12 months after IOL implantation
To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation
Secondary Outcomes
- Secondary onjective(12 months after IOL implantation)