ClinicalTrials.gg
CompletedNCT03452969Updated Oct 10, 2018

Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

An observational study in Visual Acuity, sponsored by University Clinic Frankfurt. Completed at 1 site in Germany. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-10.

Sponsored by University Clinic Frankfurt · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
45 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Patient Satisfaction with a site in Germany — 3 open to participants now, 3 under way, none of them phase 3. Patient Satisfaction · Germany.

Enrollment
11th of 12
25 · median 116
Started
2014
with 1 other
Observational
12 of 22
none open now
Registered
12th of 22
by date
Lead sponsor
2 of 22
University Clinic Frankfurt

Among the 22 studies in Patient Satisfaction with a site in Germany, this one is the 11th largest by enrollment of the 12 observational ones that give a count, is one of 2 that started in 2014, is one of 12 observational ones, and was the 12th registered.

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

Browse Patient Satisfaction studies →

Open to participants now

3 of the 22 studies in Patient Satisfaction with a site in Germany are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.

This study: 45 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Patient Satisfaction with a site in Germany, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Visual Acuity

Browse trials for

Keywords

  • visual outcomes
  • mulitfocal intraocular lens
  • patient satisfaction
  • spectacle independence
  • contrast sensitivity
04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who received bilateral cataract surgery with the implantation of a segmental refractive multifocal intraocular lens

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • bilateral cataract
  • age > 45 years
  • corneal astigmatism ≤ 0.75 D postoperatively
  • pupil size 3 to 6 mm (mesopic)
  • center shift \< 1 mm

Exclusion criteria

Exclusion Criteria:

  • previous ocular surgeries
  • amblyopia
  • potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • OtherImplantation of multifocal intraocular lens

    Procedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.

06

What researchers measure

Primary outcomes

  1. Best corrected visual acuity at far distance

    Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery

    Time frame: Measured 3 month after lens surgery

Secondary outcomes

  1. Best corrected visual acuity at intermediate distance

    Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

    Time frame: Measured 3 month after lens surgery

  2. 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

    Time frame: Measured 3 month after lens surgery

  3. Uncorrected visual acuity at far distance

    Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery

    Time frame: Measured 3 month after lens surgery

  4. Uncorrected visual acuity at intermediate distance

    Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

    Time frame: Measured 3 month after lens surgery

  5. Uncorrected visual acuity at near distance

    Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery

    Time frame: Measured 3 month after lens surgery

  6. 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).

    Time frame: Measured 3 month after lens surgery

  7. 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).

    Time frame: Measured 3 month after lens surgery

  8. Radner reading skills

    Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts).

    Time frame: Measured 3 month after lens surgery

  9. 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.

    Time frame: Measured 3 month after lens surgery

07

Study locations

1 site
  • Department of ophthalmology University clinic Frankfurt
    Frankfurt am Main, Hessen 60590, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2014 to primary completion in May 2018, 44 months.

Of 105 non-industry observational studies under Patient Satisfaction, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 45. This study's 44 months is above that.

Counting every sponsor, half of 111 studies reached it within 20 months; a quarter within 7 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2018
First posted
Mar 2, 2018
StartActual
Aug 28, 2014
Primary completionActual
May 1, 2018
CompletionActual
May 1, 2018
Last update
Oct 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03452969
Lead sponsor
University Clinic Frankfurt
Collaborators
Oculentis GmbH
Responsible party
Myriam Böhm, MD (Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt) — Principal investigator
First posted
Mar 2, 2018
Start date
Aug 28, 2014
Primary completion
May 1, 2018
Completion
May 1, 2018
Last update
Oct 10, 2018

Study contacts

Thomas Kohnen, Professor
principal investigator · Goethe University Clinic Frankfurt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion