CataractNCT04875455
Premium Trifocal IOL Comparative Analysis
A study testing POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 4 sites in Germany.
Trial summary
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract, Lens Opacities, Presbyopia
- What is being tested?
- POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Nov 2017to 17 Nov 2021
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Bilateral implantation of one of the following IOL models
- Alcon PanOptix (TFNT00)
- PhysIOL FineVision (POD F)
- PhysIOL FineVision (POD F GF)
- Uneventful cataract surgery with first clinical outcomes in the expected range
- Patient included in Premium IOL study protocol by signed informed consent
Who cannot join
- Age of patient <45 years
- Irregular astigmatism
- Postoperative manifested astigmatism of >1.0 D
- Difficulty for cooperation (distance from their home, general health condition)
- Clinically significant glaucoma
- Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy
Show all 14Show fewer
- Patients with keratoconus or keratectasia
- Any ocular comorbidity having a significant effect on the postoperative clinical outcomes
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- AMD
- Intraoperative complications like capsular rupture etc.
- Patients who do not give informed consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Augenklinik Ahaus
Ahaus, 48683
Internationale Innovative Ophthalmochirgie
Düsseldorf, 40212
Universitäts-Augenklinik Heidelberg
Heidelberg, 69120
Augentagesklinik Rheine
Rheine, 48429
About this study
Official title: Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
Read the detailed description
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak \& Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Main objectives:
- Functional results (refraction and visual acuity results) Secondary goals:
- Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
- Subjective patient satisfaction
- Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
- Stability of the results achieved postoperatively
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Being tested
- POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
- Keywords
- Intraocular lens, Trifocal
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantationDevice
In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation | Experimental | PhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated. Receives: Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Best corrected distance visual acuity (5 m)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
Measured: Postoperative Day 75-105 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Nov 2017
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study procedure guidelines Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included: Retrospective: Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively Prospective: 2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerd Auffarth, MD, PhD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875455
- Sponsor's protocol ID
- PHY1705
- Status last verified
- Jan 2022
- First submitted
- 1 May 2021
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses
- ClinicalTrials.gov ID
- NCT04875455
- Acronym / sponsor ID
- PHY1705
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Keywords
- Intraocular lens, Trifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 6 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.
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
Detailed description
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak \& Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Main objectives:
- Functional results (refraction and visual acuity results) Secondary goals:
- Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
- Subjective patient satisfaction
- Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
- Stability of the results achieved postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study procedure guidelines Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included: Retrospective: Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively Prospective: 2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular
| Arm | Type | Receives |
|---|---|---|
| Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation | Experimental | Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantationPhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Bilateral implantation of one of the following IOL models
- Alcon PanOptix (TFNT00)
- PhysIOL FineVision (POD F)
- PhysIOL FineVision (POD F GF)
Key exclusion criteria (14 listed)
- Age of patient <45 years
- Irregular astigmatism
- Postoperative manifested astigmatism of >1.0 D
- Difficulty for cooperation (distance from their home, general health condition)
- Clinically significant glaucoma
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 |
|---|---|---|
| POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantationIn this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated. | Device | Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation |
Primary outcome
Monocular Best corrected distance visual acuity (5 m)
Time frame: Postoperative Day 75-105 (3 months)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
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 11 Jan 2022.
- 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.
Gerd Auffarth, MD, PhD principal investigator
University Hospital Heidelberg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 4 sites in Germany.
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 7 inclusion and 14 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Monocular Best corrected distance visual acuity (5 m) (time frame: Postoperative Day 75-105 (3 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 11 Jan 2022.