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

Completed

• Conditions: Cataract

• Registration Number: NCT06469541
• Lead Sponsor: Medicontur Medical Engineering Ltd

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.

* 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 Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-11
• Study First Submitted: 2023-05-31
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-01
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NHS Ayrshire and Arran; 🇬🇧 Ayr, Scotland, United Kingdom