CataractNCT03371576
Clinical Analysis of Two Toric Intraocular Lenses
An observational study of Cataract and IOL, run by Hospital Hietzing.
Trial summary
Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract. Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- intraocular lenses
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 1 Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cataract on both eyes.
Who may be able to join
- Age related cataract on both eyes
- Corneal astigmatism 1,0- 4,0 D
- Potential postoperative visus 1,0
- No other ocular pathology as cataract
- Age 18 - 80
- Written informed consent to surgery and participation in the study
Who cannot join
- Pregnancy, breastfeeding
- Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
- Optical media disturbances due to: corneal and vitreal opacity, PEX
- Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
- ≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
- Trauma, ocular surgery performed within 6 months
- Traumatic cataract
- Potential postoperative visus under 1,0
About this study
Official title: Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.
Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.
- Being tested
- intraocular lenses
- Keywords
- toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lensesDevice
| Study group | Role | What they receive |
|---|---|---|
| 2 different torical intraocular lenses | Not described Receives: Device: intraocular lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected visual acuity
visual acuity in logMARon an ETDRS Chart
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start1 Jun 2012
- Primary completion1 Aug 2015
- Study completion1 Sep 2017
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)
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
- NCT03371576
- Sponsor's protocol ID
- HHietzing
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mihaltz K, Lasta M, Burgmuller M, Vecsei-Marlovits PV, Weingessel B. Comparison of Two Toric IOLs with Different Haptic Design: Optical Quality after 1 Year. J Ophthalmol. 2018 Feb 11;2018:4064369. doi: 10.1155/2018/4064369. eCollection 2018.
PubMed 29607216
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
- ClinicalTrials.gov ID
- NCT03371576
- Acronym / sponsor ID
- HHietzing
- Keywords
- toric IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 13 Dec 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: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.
Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 different torical intraocular lenses | – | Device: intraocular lenses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cataract on both eyes.
Key inclusion criteria (6 listed)
- Age related cataract on both eyes
- Corneal astigmatism 1,0- 4,0 D
- Potential postoperative visus 1,0
- No other ocular pathology as cataract
- Age 18 - 80
Key exclusion criteria (8 listed)
- Pregnancy, breastfeeding
- Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
- Optical media disturbances due to: corneal and vitreal opacity, PEX
- Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
- ≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
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 lenses | Device | 2 different torical intraocular lenses |
Primary outcome
uncorrected visual acuity
Time frame: 1 year
visual acuity in logMARon an ETDRS Chart
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 13 Dec 2017.
- Derived from this study: PubMed 29607216Mihaltz K, Lasta M, Burgmuller M, Vecsei-Marlovits PV, Weingessel B. Comparison of Two Toric IOLs with Different Haptic Design: Optical Quality after 1 Year. J Ophthalmol. 2018 Feb 11;2018:4064369. doi: 10.1155/2018/4064369. eCollection 2018.
- 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 Cataract and IOL, 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 6 inclusion and 8 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 13 Dec 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?
uncorrected visual acuity (time frame: 1 year). 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 NCT03371576, 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 13 Dec 2017.