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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06469541

Enrollment

100

Registered

2024-06-21

Start date

2023-04-11

Completion date

2023-12-01

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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. * 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary objective	12 months after IOL implantation	To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation

Secondary

Measure	Time frame	Description
Secondary onjective	12 months after IOL implantation	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

Countries

United Kingdom

Outcome results