Cataract SenileBidofNCT05303571
Project Bidof - Monovision by Pairing Bifocal and EDOF Lens
An observational study of Cataract Senile, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Cataract Senile
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 14 Mar 2022to 14 Mar 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient between 21 and 99 years after cataract surgery
Who may be able to join
- Age between 21 and 99 years
- signed informed consent form
- condition after cataract surgery
Who cannot join
- no signed informed consent form
- laser treatment of the Cornea
- macular pathologies
- corneal pathologies
- irregular astigmatism
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology
Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.
- Conditions
- Cataract Senile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monodof | monofocal and EDOF lens | |
| Bidof | Bifocal and EDOF lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2
Measured: 6 months
Intermediate Visual Acuity
percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2
Measured: 6 months
Near Visual Acuity
percentage of patients with binocular near visual acuity logmar < 0.2
Measured: 6 months
Secondary outcomes (3)
contrast vision
contrast sensitivity vision
Measured: 3 months
Halo and Glare
Halo and Glare Simulator
Measured: 3 months
Defocus curve
Defocus curve
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Mar 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Why it stopped: not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bolz, Johannes Kepler University of Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303571
- Sponsor's protocol ID
- KUK-Ophthalmology-005
- Acronym
- Bidof
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2022
- Last updated
- 7 Mar 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology
- ClinicalTrials.gov ID
- NCT05303571
- Acronym / sponsor ID
- Bidof / KUK-Ophthalmology-005
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 31 Mar 2022 (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.
Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monodof | – | –monofocal and EDOF lens |
| Bidof | – | –Bifocal and EDOF lens |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient between 21 and 99 years after cataract surgery
Key inclusion criteria (3 listed)
- Age between 21 and 99 years
- signed informed consent form
- condition after cataract surgery
Key exclusion criteria (6 listed)
- no signed informed consent form
- laser treatment of the Cornea
- macular pathologies
- corneal pathologies
- irregular astigmatism
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
Distance Visual Acuity
Time frame: 6 months
percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2
Intermediate Visual Acuity
Time frame: 6 months
percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2
Near Visual Acuity
Time frame: 6 months
percentage of patients with binocular near visual acuity logmar < 0.2
3 secondary outcomes
contrast vision
Time frame: 3 months
Halo and Glare
Time frame: 3 months
Defocus curve
Time frame: 3 and 6 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 7 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Senile, run by Johannes Kepler University of Linz at 1 site in Austria.
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 6 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 7 Mar 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 Austria. 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 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?
Distance Visual Acuity (time frame: 6 months). The study lists 3 primary outcomes in all. 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 7 Mar 2024.