CataractNCT01995630
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
A study testing AMO Tecnis ZA9003 and AMO Sensar AR40e in people with Cataract and Spherical Aberrations, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Spherical Aberrations, Intraocular Lenses
- What is being tested?
- AMO Tecnis ZA9003 and AMO Sensar AR40e
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to 26 Jun 2016
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively
Who cannot join
- Uveitis, pathology of the retina or the optic nerve
- Corneal scarring or irregularities
- Astigmatism >1.5 D
- Amblyopia
- Perioperative complications
- Postoperative refractive error >2.0 D of spherical equivalent
- Postoperative DCVA <0.8 (ETDRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial
The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.
- Conditions
- Cataract, Spherical Aberrations, Intraocular Lenses, Depth of Focus
- Being tested
- AMO Tecnis ZA9003, AMO Sensar AR40e
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMO Tecnis ZA9003Device
AMO Sensar AR40eDevice
| Study group | Role | What they receive |
|---|---|---|
| Hypermetropic, spherical IOL | Experimental | AMO Sensar AR40e Receives: Device: AMO Sensar AR40e |
| Hypermetropic, aspheric IOL | Experimental | AMO Tecnis ZA9003 Receives: Device: AMO Tecnis ZA9003 |
| Emmetropic, spherical IOL | Active comparator | AMO Sensar AR40e Receives: Device: AMO Sensar AR40e |
| Emmetropic, aspheric IOL | Active comparator | AMO Tecnis ZA9003 Receives: Device: AMO Tecnis ZA9003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-corrected intermediate visual acuity
Measured: 3 month postop
Secondary outcomes (10)
Distance-corrected near visual acuity
Measured: 3 month postop
Uncorrected distance visual acuity
Measured: 3 month postop
Corrected distance visual acuity
Measured: 3 month postop
Uncorrected near visual acuity
Measured: 3 month postop
Corrected near visual acuity
Measured: 3 month postop
Pseudoaccomodation
Measured: 3 month postop
Photopic contrast sensitivity
Measured: 3 month postop
Mesopic contrast sensitivity
Measured: 3 month postop
Spherical aberrations
Measured: 3 month postop
High order aberrations
Measured: 3 month postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completion26 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navid Ardjomand, Medical University of Graz
- Investigators
- Navid Ardjomand, MD, Principal investigator, Dept. of Ophthalmology, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995630
- Sponsor's protocol ID
- SIOLvsAIOL
- Status last verified
- Jun 2017
- First submitted
- 21 Nov 2013
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01995630
- Acronym / sponsor ID
- SIOLvsAIOL
- Conditions
- Cataract, Spherical Aberrations, Intraocular Lenses, Depth of Focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 26 Jun 2016 (actual)
- First posted
- 26 Nov 2013 (estimated)
- 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.
The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypermetropic, spherical IOL | Experimental | Device: AMO Sensar AR40eAMO Sensar AR40e |
| Hypermetropic, aspheric IOL | Experimental | Device: AMO Tecnis ZA9003AMO Tecnis ZA9003 |
| Emmetropic, spherical IOL | Active comparator | Device: AMO Sensar AR40eAMO Sensar AR40e |
| Emmetropic, aspheric IOL | Active comparator | Device: AMO Tecnis ZA9003AMO Tecnis ZA9003 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract
- Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively
Key exclusion criteria (7 listed)
- Uveitis, pathology of the retina or the optic nerve
- Corneal scarring or irregularities
- Astigmatism >1.5 D
- Amblyopia
- Perioperative complications
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 |
|---|---|---|
| AMO Tecnis ZA9003 | Device | Emmetropic, aspheric IOL, Hypermetropic, aspheric IOL |
| AMO Sensar AR40e | Device | Emmetropic, spherical IOL, Hypermetropic, spherical IOL |
Primary outcome
Distance-corrected intermediate visual acuity
Time frame: 3 month postop
10 secondary outcomes
Distance-corrected near visual acuity
Time frame: 3 month postop
Uncorrected distance visual acuity
Time frame: 3 month postop
Corrected distance visual acuity
Time frame: 3 month postop
Uncorrected near visual acuity
Time frame: 3 month postop
Corrected near visual acuity
Time frame: 3 month postop
Pseudoaccomodation
Time frame: 3 month postop
Photopic contrast sensitivity
Time frame: 3 month postop
Mesopic contrast sensitivity
Time frame: 3 month postop
Spherical aberrations
Time frame: 3 month postop
High order aberrations
Time frame: 3 month postop
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 28 Jun 2017.
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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.
Navid Ardjomand, MD principal investigator
Dept. of Ophthalmology, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMO Tecnis ZA9003 and AMO Sensar AR40e in people with Cataract and Spherical Aberrations, run by Medical University of Graz 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 2 inclusion and 7 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 28 Jun 2017. 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?
Distance-corrected intermediate visual acuity (time frame: 3 month postop). 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 28 Jun 2017.