Cataract SenileNCT05347615
Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
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
- What is being tested?
- IOL Implantation:EDOF lens and IOL Implantation: Monofocal lens
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteAustria
- Study dates
- 10 Oct 2019to 12 May 2021
- 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: male and female patients with senile cataract undergoing surgery
Who may be able to join
- Patient age between 21-99 years
- signed consent form
- senile cataract LOCS III grading
- Cataract surgery with monofocal or premium lens implantation
Who cannot join
- missing signed consent form
- macular pathologies
- corneal pathologies
- irregular astigmatism
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implantation Of Monofocal And Premium IOL Models - A Registry Study At The Kepler University Hospital
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 monofocal 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 "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.
- Conditions
- Cataract Senile
- Being tested
- IOL Implantation:EDOF lens, IOL Implantation: Monofocal lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL Implantation:EDOF lensProcedure or surgery
A EDOF lens is implanted in the dominant eye
IOL Implantation: Monofocal lensProcedure or surgery
A monofocal lens is implanted in the non dominant eye.
| Study group | Role | What they receive |
|---|---|---|
| EDOF | Eye after EDOF lens Implantation Receives: Procedure: IOL Implantation:EDOF lens | |
| Monofocal | Eye after Monofocal lens Implantation Receives: Procedure: IOL Implantation: Monofocal lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected distance visual acuity
Percentage of patients with uncorrected distance visual acuity of logMAR >0.1
Measured: 24 months
uncorrected intermediate distance visual acuity
Percentage of patients with uncorrected intermediate distance visual acuity of logMAR >0.2
Measured: 24 months
uncorrected near visual acuity
Percentage of patients with uncorrected near visual acuity of logMAR >0.2
Measured: 24 months
Secondary outcomes (3)
Dysphotopsia
Quality of Vision questionnaire
Measured: 24 months
PRISQ-Questionnaire
questionnaire rating spectacle independency
Measured: 24 months
Patient Satisfaction
Catquest 9-SF-Questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start10 Oct 2019
- Primary completion12 May 2021
- Study completion12 May 2021
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
- 29 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
- NCT05347615
- Sponsor's protocol ID
- KUK-Ophthalmology-006
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implantation Of Monofocal And Premium IOL Models - A Registry Study At The Kepler University Hospital
- ClinicalTrials.gov ID
- NCT05347615
- Acronym / sponsor ID
- KUK-Ophthalmology-006
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 26 Apr 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 monofocal 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 "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDOF | – | Procedure: IOL Implantation:EDOF lensEye after EDOF lens Implantation |
| Monofocal | – | Procedure: IOL Implantation: Monofocal lensEye after Monofocal lens Implantation |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female patients with senile cataract undergoing surgery
Key inclusion criteria (4 listed)
- Patient age between 21-99 years
- signed consent form
- senile cataract LOCS III grading
- Cataract surgery with monofocal or premium lens implantation
Key exclusion criteria (5 listed)
- missing signed consent form
- macular pathologies
- corneal pathologies
- irregular astigmatism
- pregnancy
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 |
|---|---|---|
| IOL Implantation:EDOF lensA EDOF lens is implanted in the dominant eye | Procedure or surgery | EDOF |
| IOL Implantation: Monofocal lensA monofocal lens is implanted in the non dominant eye. | Procedure or surgery | Monofocal |
Primary outcome
uncorrected distance visual acuity
Time frame: 24 months
Percentage of patients with uncorrected distance visual acuity of logMAR >0.1
uncorrected intermediate distance visual acuity
Time frame: 24 months
Percentage of patients with uncorrected intermediate distance visual acuity of logMAR >0.2
uncorrected near visual acuity
Time frame: 24 months
Percentage of patients with uncorrected near visual acuity of logMAR >0.2
3 secondary outcomes
Dysphotopsia
Time frame: 24 months
PRISQ-Questionnaire
Time frame: 24 months
Patient Satisfaction
Time frame: 24 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 26 Apr 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.
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 4 inclusion and 5 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 26 Apr 2022. 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 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?
uncorrected distance visual acuity (time frame: 24 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 26 Apr 2022.