CataractNCT03224728
Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses
An observational study of Cataract, run by Hospital Hietzing.
Trial summary
Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- intraocular lens
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2016
- How long will I take part?
- 3 Months
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Men and women between 50 and 85 years with age related cataract
Who may be able to join
- Bilateral age-related cataract
- Potential postoperative visual acuity of 1.0 Snellen
- No relevant ocular pathology other than cataract
- Written informed consent to surgery and participation in the study
Who cannot join
- Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
- Optical media disturbances due to: corneal and vitreal opacity, PEX
- Preceding ocular trauma or ocular surgery within 6 months
- Inability to cooperate
- Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)
About this study
Official title: Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses
Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.
- Conditions
- Cataract
- Being tested
- intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lensDevice
| Study group | Role | What they receive |
|---|---|---|
| 2 different Intraocular lenses | 2 different intraocular lenses were compared Receives: Device: intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation transfer function (MTF) at 3 months after surgery
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 posted21 Jul 2017
- Study startSep 2015
- Primary completionJun 2016
- Study completionDec 2016
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 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
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Lasta, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224728
- Sponsor's protocol ID
- EK-12-256-0113
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lasta M, Mihaltz K, Kovacs I, Vecsei-Marlovits PV. Effect of Spherical Aberration on the Optical Quality after Implantation of Two Different Aspherical Intraocular Lenses. J Ophthalmol. 2017;2017:8039719. doi: 10.1155/2017/8039719. Epub 2017 Aug 16.
PubMed 28900544
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03224728
- Acronym / sponsor ID
- EK-12-256-0113
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Jul 2017 (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 compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 different Intraocular lenses | – | Device: intraocular lens2 different intraocular lenses were compared |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women between 50 and 85 years with age related cataract
Key inclusion criteria (4 listed)
- Bilateral age-related cataract
- Potential postoperative visual acuity of 1.0 Snellen
- No relevant ocular pathology other than cataract
- Written informed consent to surgery and participation in the study
Key exclusion criteria (5 listed)
- Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
- Optical media disturbances due to: corneal and vitreal opacity, PEX
- Preceding ocular trauma or ocular surgery within 6 months
- Inability to cooperate
- Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)
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 |
|---|---|---|
| intraocular lens | Device | 2 different Intraocular lenses |
Primary outcome
Modulation transfer function (MTF) at 3 months after surgery
Time frame: 3 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 21 Jul 2017.
- Derived from this study: PubMed 28900544Lasta M, Mihaltz K, Kovacs I, Vecsei-Marlovits PV. Effect of Spherical Aberration on the Optical Quality after Implantation of Two Different Aspherical Intraocular Lenses. J Ophthalmol. 2017;2017:8039719. doi: 10.1155/2017/8039719. Epub 2017 Aug 16.
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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 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 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 21 Jul 2017. 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?
Modulation transfer function (MTF) at 3 months after surgery (time frame: 3 months). 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 NCT03224728, 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 Jul 2017.