Clinical Outcomes After Implantation of… | Clinical Trial

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Ayrshire and Arran

Ayr, Scotland, KA7 2SP, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Official study 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)

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 21, 2024
Registry last updated: Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed