Visual AcuityNCT03223857
To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses
An observational study of Visual Acuity, run by University Clinic Frankfurt at 1 site in Germany.
Trial summary
To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Femtosecond-laser-assisted lens exchange
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 9 Apr 2013to 23 Mar 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens
Who may be able to join
- bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens
- a regular corneal astigmatism < 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)
Who cannot join
- other previous ocular surgeries
- ocular pathologies
- corneal abnormalities
- endothelial cell count below 2000/mm²
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of ophthalmology University clinic Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
Official title: Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens
To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.
Read the detailed description
This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.
Patients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of >1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.
- Conditions
- Visual Acuity
- Being tested
- Femtosecond-laser-assisted lens exchange
- Keywords
- visual outcomes, multifocal intraocular lens, patient satisfaction, spectacle independence
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond-laser-assisted lens exchangeProcedure or surgery
Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity at intermediate distance
Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Secondary outcomes (7)
Best corrected visual acuity at far distance
Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Best corrected visual acuity at near distance
Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Uncorrected visual acuity at far distance
Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Uncorrected visual acuity at intermediate distance
Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Uncorrected visual acuity at near distance
Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions
Binocular contrast sensitivity (CS) was measured under photopic, mesopic (0.167 cd/m²), and mesopic with glare lighting conditions by means of the "Frankfurt-Freiburg Contrast and Acuity Test System" (FF-CATS)
Measured: Measured 3 month after lens surgery
Defocus curve testing
Defocus curve (monocular and binocular) was tested from -5.0 D to +2.0 D in 0.5 D steps under photopic lighting conditions (ETDRS).
Measured: Measured 3 month after lens surgery
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 start9 Apr 2013
- Primary completion23 Dec 2018
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myriam Böhm, MD, University Clinic Frankfurt
- Investigators
- Thomas Kohnen, Professor, Study chair, Goethe University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223857
- Sponsor's protocol ID
- 102/13
- Status last verified
- Mar 2019
- First submitted
- 18 Jul 2017
- Last updated
- 25 Mar 2019
- 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 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens
- ClinicalTrials.gov ID
- NCT03223857
- Acronym / sponsor ID
- 102/13
- Conditions
- Visual Acuity
- Keywords
- visual outcomes, multifocal intraocular lens, patient satisfaction, spectacle independence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Mar 2019 (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.
To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.
Detailed description
This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.
Patients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of >1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens
Key inclusion criteria (2 listed)
- bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens
- a regular corneal astigmatism < 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)
Key exclusion criteria (4 listed)
- other previous ocular surgeries
- ocular pathologies
- corneal abnormalities
- endothelial cell count below 2000/mm²
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 |
|---|---|---|
| Femtosecond-laser-assisted lens exchangeBilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange | Procedure or surgery | – |
Primary outcome
Best corrected visual acuity at intermediate distance
Time frame: Measured 3 month after lens surgery
Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery
7 secondary outcomes
Best corrected visual acuity at far distance
Time frame: Measured 3 month after lens surgery
Best corrected visual acuity at near distance
Time frame: Measured 3 month after lens surgery
Uncorrected visual acuity at far distance
Time frame: Measured 3 month after lens surgery
Uncorrected visual acuity at intermediate distance
Time frame: Measured 3 month after lens surgery
Uncorrected visual acuity at near distance
Time frame: Measured 3 month after lens surgery
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions
Time frame: Measured 3 month after lens surgery
Defocus curve testing
Time frame: Measured 3 month after lens surgery
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 25 Mar 2019.
- 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.
Thomas Kohnen, Professor study chair
Goethe University Clinic Frankfurt
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 Visual Acuity, run by University Clinic Frankfurt 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 2 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: finished, as of the sponsor's last update on 25 Mar 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?
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?
Best corrected visual acuity at intermediate distance (time frame: Measured 3 month after lens surgery). 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 25 Mar 2019.