Refractive ErrorsNCT03292614

Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

An observational study of Refractive Errors, run by Dietrich-Bonhoeffer-Klinikum at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This Study determines the most precise method for measuring post-operative refraction following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of Refraction of the different Autorefractor Keratometers with the subjective measurements for distance and near. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Errors
What is being tested?: Measurements of the postoperative refraction
How many people: 25 participants
Where: 1 siteGermany
Study dates: 1 Jun 2017to 1 Jun 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: up to 100 eyes

Who may be able to join

Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study

Who cannot join

significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary cataract

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, Mecklenburg-Vorpommern, 17036

Other trials in Germany

About this study

Official title: Measurement of Refraction Following Cataract Surgery With Implantation of MICS Intraocular Lens LS313 MF30, Oculentis Berlin

Read the detailed description

This is a post market study without invasive interventions. The patients have been treated with cataract surgery and MIOL Implantation at least 3 months ago. They will be invited for only one follow up visit to measure the postoperative refraction with different Autorefractor-Keratometers, a Manual Refractometer, the test device "iTrace" and with determination of the subjective refraction for distance and near with the appropriate corrections at the Department of Ophthalmology in Neubrandenburg, Germany.

Conditions: Refractive Errors
Being tested: Measurements of the postoperative refraction
Keywords: Multifocal Intraocular Lens, Postoperative Measurements of refraction
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measurements of the postoperative refractionDiagnostic test
The Measurements of the postoperative refraction will be performed with the following devices:
Autorefractor Keratometers:
Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany)
Manual Refractometer:
Eye refractometer PR 60 or PR 50 (Rodenstock, Munich),
Test device:
iTrace (TraceyTechnologies, Houston, Texas, USA),
Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)

Study groups in NCT03292614
Study group	Role	What they receive
Multifocal intraocular lens implantation		Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction Receives: Diagnostic Test: Measurements of the postoperative refraction

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30
After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction.
A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)).
KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones.
The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter.
The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm.
The results of all refractometers are compared with the subjective refraction.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20171 Jun 2019

First posted25 Sep 2017
Study start1 Jun 2017
Primary completion31 Jan 2019
Study completion1 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Refractive ErrorsStudies 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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03292614
Sponsor's protocol ID: STI 02/17
Status last verified: Aug 2019
First submitted: 21 Sep 2017
Last updated: 26 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Results will be published in ophthalmological journals (Individual participant date will not be provided).

Publications

Kretz FT, Linz K, Mueller M, Gerl M, Koss MJ, Gerl RH, Auffarth GU. [Refraction after Implantation of Multifocal and Presbyopia-Correcting Intraocular Lenses]. Klin Monbl Augenheilkd. 2015 Aug;232(8):953-6. doi: 10.1055/s-0035-1545832. Epub 2015 Apr 30. German.
PubMed 25927177
Munoz G, Albarran-Diego C, Sakla HF. Validity of autorefraction after cataract surgery with multifocal ReZoom intraocular lens implantation. J Cataract Refract Surg. 2007 Sep;33(9):1573-8. doi: 10.1016/j.jcrs.2007.05.024.
PubMed 17720072
Bissen-Miyajima H, Minami K, Yoshino M, Nishimura M, Oki S. Autorefraction after implantation of diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2010 Apr;36(4):553-6. doi: 10.1016/j.jcrs.2009.10.047.
PubMed 20362844
van der Linden JW, Vrijman V, Al-Saady R, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Autorefraction versus subjective refraction in a radially asymmetric multifocal intraocular lens. Acta Ophthalmol. 2014 Dec;92(8):764-8. doi: 10.1111/aos.12410. Epub 2014 Apr 27.
PubMed 24767468
Munoz G, Albarran-Diego C, Sakla HF. Autorefraction after multifocal IOLs. Ophthalmology. 2007 Nov;114(11):2100. doi: 10.1016/j.ophtha.2007.05.049. No abstract available.
PubMed 17980752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of Refraction Following Cataract Surgery With Implantation of MICS Intraocular Lens LS313 MF30, Oculentis Berlin
ClinicalTrials.gov ID: NCT03292614
Acronym / sponsor ID: STI 02/17
Conditions: Refractive Errors
Keywords: Multifocal Intraocular Lens, Postoperative Measurements of refraction
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Dietrich-Bonhoeffer-KlinikumIndustry (pharma, biotech, devices)
Study start: 1 Jun 2017 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 25 Sep 2017 (actual)
Results: Posted 26 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Multifocal intraocular lens implantation	–	Diagnostic Test: Measurements of the postoperative refractionPatients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: up to 100 eyes

Key inclusion criteria (1 listed)

Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study

Key exclusion criteria (1 listed)

significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary 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
Measurements of the postoperative refractionThe Measurements of the postoperative refraction will be performed with the following devices: Autorefractor Keratometers: Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany) Manual Refractometer: Eye refractometer PR 60 or PR 50 (Rodenstock, Munich), Test device: iTrace (TraceyTechnologies, Houston, Texas, USA), Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)	Diagnostic test	Multifocal intraocular lens implantation

Primary outcome

Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30
Time frame: one year
After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction. A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)). KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones. The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter. The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm. The results of all refractometers are compared with the subjective refraction.

Results and safety

Results posted to the registry on 26 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multifocal Intraocular Lens Implantation	25	25

Primary outcome: Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30

Time frame: one year. Mean (Standard Deviation). Unit: diopter

Measure	Multifocal Intraocular Lens Implantation n = 25
subjective Refraction	0.36 (0.65)
iTrace	0.27 (0.64)
KR-W1	-0.81 (0.59)
KR-800s	-0.78 (0.73)
ARK-760A	-0.73 (0.59)
ARK-560A	-0.76 (0.63)
PR60/50	-0.18 (0.43)

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multifocal Intraocular Lens Implantation	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25927177Kretz FT, Linz K, Mueller M, Gerl M, Koss MJ, Gerl RH, Auffarth GU. [Refraction after Implantation of Multifocal and Presbyopia-Correcting Intraocular Lenses]. Klin Monbl Augenheilkd. 2015 Aug;232(8):953-6. doi: 10.1055/s-0035-1545832. Epub 2015 Apr 30. German.
Background: PubMed 17720072Munoz G, Albarran-Diego C, Sakla HF. Validity of autorefraction after cataract surgery with multifocal ReZoom intraocular lens implantation. J Cataract Refract Surg. 2007 Sep;33(9):1573-8. doi: 10.1016/j.jcrs.2007.05.024.
Background: PubMed 20362844Bissen-Miyajima H, Minami K, Yoshino M, Nishimura M, Oki S. Autorefraction after implantation of diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2010 Apr;36(4):553-6. doi: 10.1016/j.jcrs.2009.10.047.
Background: PubMed 24767468van der Linden JW, Vrijman V, Al-Saady R, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Autorefraction versus subjective refraction in a radially asymmetric multifocal intraocular lens. Acta Ophthalmol. 2014 Dec;92(8):764-8. doi: 10.1111/aos.12410. Epub 2014 Apr 27.
Background: PubMed 17980752Munoz G, Albarran-Diego C, Sakla HF. Autorefraction after multifocal IOLs. Ophthalmology. 2007 Nov;114(11):2100. doi: 10.1016/j.ophtha.2007.05.049. No abstract available.
Individual participant dataSharing planned: Yes. Results will be published in ophthalmological journals (Individual participant date will not be provided).

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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.

Helmut Hoeh, MD, FEBO principal investigator

Department of Ophthalmology, Neubrandenburg, Germany

Vitaliy Klishko study chair

Department of Ophthalmology, Neubrandenburg, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Refractive Errors, run by Dietrich-Bonhoeffer-Klinikum at 1 site in Germany.

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 26 Sep 2019. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 (time frame: one 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 NCT03292614, which also lists 5 linked publications.

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 26 Sep 2019.