Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector

Medicontur Medical Engineering Ltd100 enrolled

Overview

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. * 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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Cataract

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Patients with regular post-operative visits over 12 months period after surgery. 3. Patients of any age above 18 years and any medical history who are eligible according the investigator's decision. Exclusion Criteria: 1. preoperative corneal astigmatism \> 1.5 D 2. uncontrolled diabetic retinopathy 3. iris neovascularisation 4. serious intraoperative complications

Locations (1)

NHS Ayrshire and Arran

Ayr, Scotland, United Kingdom

Outcomes

Primary Outcomes

Primary objective

To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation

Time frame: 12 months after IOL implantation

Secondary Outcomes

Secondary onjective

To evaluate the spherical equivalent refraction one month postoperatively. To evaluate level of astigmatism one month postoperatively. 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

Time frame: 12 months after IOL implantation

Data from ClinicalTrials.gov

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