CataractNCT04907318
Comparison Between a Toric Monofocal and Multifocal Intraocular Lens
An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.
Trial summary
The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2016to 1 Jul 2016
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher and had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Who may be able to join
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
- PEX patients (pseudoexfoliation syndrome) can be included.
Who cannot join
- To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
- In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
Show all 15Show fewer
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.
Read the detailed description
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria. 3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.
The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.
The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).
The intraoperative data will be the power of the implant and any complications, if applicable.
The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).
4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.
Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.
Changes will determine its stability in the coronal plane around the visual axis.
The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.
The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- IOL, Toric, Multifocal
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDevice
| Study group | Role | What they receive |
|---|---|---|
| ANKORIS | Cataract surgery performed with POD26PAYT Receives: Device: Cataract surgery | |
| FINEVISION TORIC | Cataract surgery performed with POD26PAYFT Receives: Device: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the rotational stability of the implant
Observation of rotational stability of the implant
Measured: 6 Months
Secondary outcomes (1)
Visual Acuity
To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jan 2016
- Primary completion1 Jun 2016
- Study completion1 Jul 2016
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristof Vandekerckhove, MD, Principal investigator, Vista Alpina Eye Cente, Visp, Switzerland, 3930
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907318
- Sponsor's protocol ID
- PHY PODT-POD FT
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
- ClinicalTrials.gov ID
- NCT04907318
- Acronym / sponsor ID
- PHY PODT-POD FT
- Conditions
- Cataract
- Keywords
- IOL, Toric, Multifocal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 28 May 2021 (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 primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.
Detailed description
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria. 3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.
The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.
The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).
The intraoperative data will be the power of the implant and any complications, if applicable.
The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).
4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.
Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.
Changes will determine its stability in the coronal plane around the visual axis.
The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.
The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANKORIS | – | Device: Cataract surgeryCataract surgery performed with POD26PAYT |
| FINEVISION TORIC | – | Device: Cataract surgeryCataract surgery performed with POD26PAYFT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher and had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Key inclusion criteria (4 listed)
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
- PEX patients (pseudoexfoliation syndrome) can be included.
Key exclusion criteria (15 listed)
- To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery | Device | ANKORIS, FINEVISION TORIC |
Primary outcome
To observe the rotational stability of the implant
Time frame: 6 Months
Observation of rotational stability of the implant
1 secondary outcome
Visual Acuity
Time frame: 6 Months
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 2 Jun 2021.
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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.
Kristof Vandekerckhove, MD principal investigator
Vista Alpina Eye Cente, Visp, Switzerland, 3930
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 Beaver-Visitec International, Inc. at 1 site in Switzerland.
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 4 inclusion and 15 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 2 Jun 2021. 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 Switzerland. 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?
To observe the rotational stability of the implant (time frame: 6 Months). 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 2 Jun 2021.