Clinical trial NCT06469541: Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The enrolled subjects will be the patients who underwent cataract surgery in one or both eyes and who were implanted with Bi-Flex 877PAY IOL mono- or bilaterally. For evaluation of records consecutive implanted patients with regular post-operative visits over a 12 months period will be included.

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

Eligibility criteria: 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

Primary outcomes:
measure: Primary objective
timeFrame: 12 months after IOL implantation
Secondary outcomes:
measure: Secondary onjective
timeFrame: 12 months after IOL implantation
Other outcomes:
Locations:
city: Ayr
country: United Kingdom
facility: NHS Ayrshire and Arran
state: Scotland
Study officials:
affiliation: NHS Ayrshire and Arran
name: Sathish Srinivasan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: