CataractNCT06469541
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector
An observational study of Cataract, run by Medicontur Medical Engineering Ltd at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- preoperative corneal astigmatism > 1.5 D
- uncontrolled diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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:
- 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
- Conditions
- Cataract
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation
Measured: 12 months after IOL implantation
Secondary outcomes (1)
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
Measured: 12 months after IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start11 Apr 2023
- Primary completion31 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicontur Medical Engineering Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sathish Srinivasan, Prof., Principal investigator, NHS Ayrshire and Arran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469541
- Sponsor's protocol ID
- M-877PAY-UK-2008
- Status last verified
- Apr 2023
- First submitted
- 31 May 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06469541
- Acronym / sponsor ID
- M-877PAY-UK-2008
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- preoperative corneal astigmatism > 1.5 D
- uncontrolled diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective
Time frame: 12 months after IOL implantation
To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation
1 secondary outcome
Secondary onjective
Time frame: 12 months after IOL implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sathish Srinivasan, Prof. principal investigator
NHS Ayrshire and Arran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Medicontur Medical Engineering Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 12 months after IOL implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.