CataractNCT02426385
Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)
An observational study of Cataract, run by Beaver-Visitec International, Inc..
Trial summary
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- FineVision Toric
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pseudophakic patients implanted with one of the two IOLs
Who may be able to join
- Patient older than 50 years old
- Regular corneal astigmatism >1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- Regular corneal astigmatism <2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
- Group 2: patients after cataract surgery with Ankoris implanted in both eyes
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- - Irregular astigmatism
- Difficulty for cooperation (distance from their home, general health condition)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- 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)
Show all 9Show fewer
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- IOL spherical equivalent power lower than 10 D or greater than 30D
- Complicated surgery
About this study
Official title: Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC
Read the detailed description
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .
The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.
- Conditions
- Cataract
- Being tested
- FineVision Toric
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FineVision ToricDevice
Posterior chamber IOL which consists in a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye
| Study group | Role | What they receive |
|---|---|---|
| 1POD26PFT | Patients implanted with the POD 26% FineVision Toric Receives: Device: FineVision Toric | |
| 2POD26PT | Patients implanted with the POD 26% Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.
Measured: 3 months
Secondary outcomes (1)
The secondary objective is to measure far and intermediate visual acuity, the refraction, centration, rotational stability and to determine the amount of photic phenomena for both IOLs: POD 26% FINEVISION TORIC and POD 26% TORIC.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: lack of suitable patients
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426385
- Sponsor's protocol ID
- TaneriPODAYFT/PODAYT
- Status last verified
- May 2021
- First submitted
- 21 Apr 2015
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision
- ClinicalTrials.gov ID
- NCT02426385
- Acronym / sponsor ID
- TaneriPODAYFT/PODAYT
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of suitable patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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 study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC
Detailed description
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .
The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1POD26PFT | – | Device: FineVision ToricPatients implanted with the POD 26% FineVision Toric |
| 2POD26PT | – | –Patients implanted with the POD 26% Toric |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pseudophakic patients implanted with one of the two IOLs
Key inclusion criteria (6 listed)
- Patient older than 50 years old
- Regular corneal astigmatism >1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- Regular corneal astigmatism <2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
- Group 2: patients after cataract surgery with Ankoris implanted in both eyes
Key exclusion criteria (9 listed)
- - Irregular astigmatism
- Difficulty for cooperation (distance from their home, general health condition)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
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 |
|---|---|---|
| FineVision ToricPosterior chamber IOL which consists in a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye | Device | 1POD26PFT |
Primary outcome
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.
Time frame: 3 months
1 secondary outcome
The secondary objective is to measure far and intermediate visual acuity, the refraction, centration, rotational stability and to determine the amount of photic phenomena for both IOLs: POD 26% FINEVISION TORIC and POD 26% TORIC.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Beaver-Visitec International, Inc..
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2. (time frame: 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 6 May 2021.