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

Cataract Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06469541
• Other study ID #: M-877PAY-UK-2008
• Status: Completed
• Start date: April 11, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
United Kingdom	NHS Ayrshire and Arran	Ayr	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

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