IOL, CataractNCT04274088
The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.
An observational study of IOL, Cataract, run by Hospital Hietzing.
Trial summary
Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IOL, Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2018
- 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 80 years
- All sexes
- Adult, Older adult
Study population: patients of the clinic
Who may be able to join
- corneal astigmatism less than 1 diopter
Who cannot join
- ocular pathology others than cataract
About this study
Official title: The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values
Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.
Read the detailed description
In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.
- Conditions
- IOL, Cataract
- Being tested
- Cataract surgery
- Keywords
- multifocal IOL, optical quality, angle alpha
- Medical subject headings
- Intraocular Lymphoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Phacoemulsification surgery
| Study group | Role | What they receive |
|---|---|---|
| Tecnis; | Patients who received the Tecnis multifocal IOL. Receives: Procedure: Cataract surgery | |
| Diffractiva | Patients who received the Diffractiva multifocal IOL. Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Schnellen VA
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IOL, 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
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kata Mihaltz, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274088
- Sponsor's protocol ID
- HHietzing3
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mihaltz K, Vecsei-Marlovits PV. The impact of visual axis position on the optical quality after implantation of multifocal intraocular lenses with different asphericity values. Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.
PubMed 33471202
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values
- ClinicalTrials.gov ID
- NCT04274088
- Acronym / sponsor ID
- HHietzing3
- Conditions
- IOL, Cataract
- Keywords
- multifocal IOL, optical quality, angle alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 18 Feb 2020 (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.
Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.
Detailed description
In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis; | – | Procedure: Cataract surgeryPatients who received the Tecnis multifocal IOL. |
| Diffractiva | – | Procedure: Cataract surgeryPatients who received the Diffractiva multifocal IOL. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients of the clinic
Key inclusion criteria (1 listed)
- corneal astigmatism less than 1 diopter
Key exclusion criteria (1 listed)
- ocular pathology others than cataract
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 surgeryPhacoemulsification surgery | Procedure or surgery | Diffractiva, Tecnis; |
Primary outcome
Visual Acuity
Time frame: 6 Month
Schnellen VA
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 21 Feb 2020.
- Derived from this study: PubMed 33471202Mihaltz K, Vecsei-Marlovits PV. The impact of visual axis position on the optical quality after implantation of multifocal intraocular lenses with different asphericity values. Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of IOL, Cataract, run by Hospital Hietzing.
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 1 inclusion and 1 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 21 Feb 2020. 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 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?
Visual Acuity (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274088, which also lists 1 linked publication.
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 21 Feb 2020.