Visual AcuityNCT03452969
Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens
An observational study of Visual Acuity, run by University Clinic Frankfurt at 1 site in Germany.
Trial summary
To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Implantation of multifocal intraocular lens
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2014to 1 May 2018
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who received bilateral cataract surgery with the implantation of a segmental refractive multifocal intraocular lens
Who may be able to join
- bilateral cataract
- age > 45 years
- corneal astigmatism ≤ 0.75 D postoperatively
- pupil size 3 to 6 mm (mesopic)
- center shift < 1 mm
Who cannot join
- previous ocular surgeries
- amblyopia
- potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR
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 Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery
To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.
Read the detailed description
Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.
Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age > 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift < 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR,
Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.
Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.
- Conditions
- Visual Acuity
- Being tested
- Implantation of multifocal intraocular lens
- Keywords
- visual outcomes, mulitfocal intraocular lens, patient satisfaction, spectacle independence, contrast sensitivity
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of multifocal intraocular lensOther
Procedure/Surgery:
Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity at far distance
Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Measured: Measured 3 month after lens surgery
Secondary outcomes (9)
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
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 with the Functional Acuity Contrast Test (FACT) chart in the Optec 6500 Vision Tester (Stereo Optical Co., Chicago, IL) under binocular photopic (85 cd/m²), mesopic (3 cd/m²), and photopic and mesopic with glare conditions at a spatial frequency of 6 cycles per degree (cpd) (threshold range 0.78-2.26).
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
Radner reading skills
Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts).
Measured: Measured 3 month after lens surgery
Optical quality questionnaire
Quality of vision questionnaire (visual analogue scale (VAS) 0 (perfect / no symptoms) to 100 (extremely poor / maximum symptom intensity)) asking for evaluation of "glare", "halos", "starbursts", "blurred vision", and "ghosting" under photopic, mesopic and scotopic light conditions, if they wear any spectacles, and to evaluate their total quality of vision.
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 posted2 Mar 2018
- Study start28 Aug 2014
- Primary completion1 May 2018
- Study completion1 May 2018
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Collaborators
- Oculentis GmbH
- Responsible party
- Principal investigator, Myriam Böhm, MD, University Clinic Frankfurt
- Investigators
- Thomas Kohnen, Professor, Principal investigator, Goethe University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452969
- Sponsor's protocol ID
- 153/14
- Status last verified
- Oct 2018
- First submitted
- 26 Feb 2018
- Last updated
- 10 Oct 2018
- 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 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT03452969
- Acronym / sponsor ID
- 153/14
- Conditions
- Visual Acuity
- Keywords
- visual outcomes, mulitfocal intraocular lens, patient satisfaction, spectacle independence, contrast sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Collaborators
- Oculentis GmbH
- Study start
- 28 Aug 2014 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 2 Mar 2018 (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 visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.
Detailed description
Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.
Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age > 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift < 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR,
Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.
Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received bilateral cataract surgery with the implantation of a segmental refractive multifocal intraocular lens
Key inclusion criteria (5 listed)
- bilateral cataract
- age > 45 years
- corneal astigmatism ≤ 0.75 D postoperatively
- pupil size 3 to 6 mm (mesopic)
- center shift < 1 mm
Key exclusion criteria (3 listed)
- previous ocular surgeries
- amblyopia
- potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR
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 |
|---|---|---|
| Implantation of multifocal intraocular lensProcedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery. | Other | – |
Primary outcome
Best corrected visual acuity at far distance
Time frame: Measured 3 month after lens surgery
Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
9 secondary outcomes
Best corrected visual acuity at intermediate 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
Radner reading skills
Time frame: Measured 3 month after lens surgery
Optical quality questionnaire
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 10 Oct 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.
Thomas Kohnen, Professor principal investigator
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 5 inclusion and 3 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 10 Oct 2018. 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 far 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 10 Oct 2018.