Cataract SenileNCT04572334
Eyhance Autorefraction Study
A study testing Auto and Subjective Refraction in people with Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Since 2018, the Tecnis Eyhance ICB00 lens (Johnson\&Johnson Vision, AMO Germany GmbH) was introduced, which is a monofocal IOL which has the ability of extended depth of focus improving intermediate vision without the photic phenomena specific for the multifocal IOLs. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Auto and Subjective Refraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2020to Mar 2021
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years old or above
- Operated age-related cataract (pseudophakic patient)
- Tecnis Eyhance ICB00 or Tecnis ZCB00 IOL implanted within 2 to 12 months prior to study related examination
Who cannot join
- Intra- or Postoperative complication
- patients with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, etc. that would significantly influence visual outcome
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Hanusch Hospital, Department of Ophthalmology
Vienna, 1140
Oliver Findl, Prof. MD, +43 1 91021 57564, office@viros.at
About this study
Official title: Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens
Since 2018, the Tecnis Eyhance ICB00 lens (Johnson\&Johnson Vision, AMO Germany GmbH) was introduced, which is a monofocal IOL which has the ability of extended depth of focus improving intermediate vision without the photic phenomena specific for the multifocal IOLs. The Tecnis Eyhance ICB00 is one of our standard IOL, routinely used in our clinic. There is no single outcome measurement that can be thought of as summarizing the efficacy of an IOL, nevertheless visual acuity and refractive outcome are the most important parameters for evaluation. Aim of this study is to determine the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens and compare the outcomes with ZCB00 lens.
Read the detailed description
This a prospective observational study that would include pseudophakic patients that have undergone cataract surgery 2 to 12 months prior. A written informed consent will be obtained from each patient. Patients with ICB00 or ZCB00 implanted lenses will be included.
Autorefraction measurements will be performed consecutively, each patient will be measured three times with each device. Two independent observers will perform subjective refraction and will be masked to the autorefraction outcome.
We would like to include 50 eyes with ICB00 and 50 eyes with ZCB00 lens implanted. For the estimation of sample size, we used data from Wang et al. (Wang L, Misra M, Palikaris IG, Koch DD. J Cataract Refract Surg 2002; 28: 276-282) that compared the refractive outcome of pseudophakic eyes and determined a mean spherical equivalent of -0.76 + 0.96 D for group I and -0.44 + 1.13 for group II, thus leading to an effect size of 0.2. The effect size was used for ANOVA test for repeated measurements within factor, with alpha < 0.05, power of 80% and a correlation of 0.5 between the two groups gave us an estimated of sample size of 42 patient. To allow patient drop out a number of 50 eyes will be included per lens group (in total 100 eyes).
When different lenses are implanted (one eye received ZCB00 and the other Eyhance), than both eyes of the patient will be included.
- Conditions
- Cataract Senile
- Being tested
- Auto and Subjective Refraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto and Subjective RefractionOther
All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction
| Study group | Role | What they receive |
|---|---|---|
| visual acuity and refractive outcome for Tecnis Eyhance | Other | Evaluation the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens Receives: Other: Auto and Subjective Refraction |
| visual acuity and refractive outcome for Tecnis ZCB00 | Other | Evaluation the comparability and reproducibility of different refraction methods in patients implanted with ZCB00 lens Receives: Other: Auto and Subjective Refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of different refraction methods
Measured: 2-12 months
Secondary outcomes (1)
Comparability between the devices (autorefractometers)
Measured: 2-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572334
- Sponsor's protocol ID
- Eyhance Autorefraction study
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Post-operative Refraction in Patients With a Novel CE Marked Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT04572334
- Acronym / sponsor ID
- Eyhance Autorefraction study
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 1 Oct 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.
Since 2018, the Tecnis Eyhance ICB00 lens (Johnson\&Johnson Vision, AMO Germany GmbH) was introduced, which is a monofocal IOL which has the ability of extended depth of focus improving intermediate vision without the photic phenomena specific for the multifocal IOLs. The Tecnis Eyhance ICB00 is one of our standard IOL, routinely used in our clinic. There is no single outcome measurement that can be thought of as summarizing the efficacy of an IOL, nevertheless visual acuity and refractive outcome are the most important parameters for evaluation. Aim of this study is to determine the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens and compare the outcomes with ZCB00 lens.
Detailed description
This a prospective observational study that would include pseudophakic patients that have undergone cataract surgery 2 to 12 months prior. A written informed consent will be obtained from each patient. Patients with ICB00 or ZCB00 implanted lenses will be included.
Autorefraction measurements will be performed consecutively, each patient will be measured three times with each device. Two independent observers will perform subjective refraction and will be masked to the autorefraction outcome.
We would like to include 50 eyes with ICB00 and 50 eyes with ZCB00 lens implanted. For the estimation of sample size, we used data from Wang et al. (Wang L, Misra M, Palikaris IG, Koch DD. J Cataract Refract Surg 2002; 28: 276-282) that compared the refractive outcome of pseudophakic eyes and determined a mean spherical equivalent of -0.76 + 0.96 D for group I and -0.44 + 1.13 for group II, thus leading to an effect size of 0.2. The effect size was used for ANOVA test for repeated measurements within factor, with alpha < 0.05, power of 80% and a correlation of 0.5 between the two groups gave us an estimated of sample size of 42 patient. To allow patient drop out a number of 50 eyes will be included per lens group (in total 100 eyes).
When different lenses are implanted (one eye received ZCB00 and the other Eyhance), than both eyes of the patient will be included.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visual acuity and refractive outcome for Tecnis Eyhance | Other | Other: Auto and Subjective RefractionEvaluation the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens |
| visual acuity and refractive outcome for Tecnis ZCB00 | Other | Other: Auto and Subjective RefractionEvaluation the comparability and reproducibility of different refraction methods in patients implanted with ZCB00 lens |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21 years old or above
- Operated age-related cataract (pseudophakic patient)
- Tecnis Eyhance ICB00 or Tecnis ZCB00 IOL implanted within 2 to 12 months prior to study related examination
Key exclusion criteria (4 listed)
- Intra- or Postoperative complication
- patients with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, etc. that would significantly influence visual outcome
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
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 |
|---|---|---|
| Auto and Subjective RefractionAll patients will be measured with three autorefractometers and two independent observes will perform subjective refraction | Other | visual acuity and refractive outcome for Tecnis Eyhance, visual acuity and refractive outcome for Tecnis ZCB00 |
Primary outcome
Reproducibility of different refraction methods
Time frame: 2-12 months
1 secondary outcome
Comparability between the devices (autorefractometers)
Time frame: 2-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto and Subjective Refraction in people with Cataract Senile, run by Vienna Institute for Research in Ocular Surgery 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, Prof., MD (+43 1 91021 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of different refraction methods (time frame: 2-12 months). 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 6 Oct 2020.