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TerminatedNCT00960700Updated Feb 8, 2013

A Multi Focal Visual Outcome Study Using Different Near Additions

An observational study in Cataract and Aphakia, sponsored by Rayner Intraocular Lenses Limited. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-08.

Sponsored by Rayner Intraocular Lenses Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study summary

A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.

02

Conditions studied

  • Cataract
  • Aphakia

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Keywords

  • MFlex
  • Multifocal
  • 630F
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 52 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Rayner Intraocular Lenses Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Aphakic adults with potential for > 20/40 visual outcome to participate in a binocular study. Subjects to be implanted bilaterally with study device.

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

  • Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact
  • Patients requiring primary IOL implantation
  • Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
  • Patients with normal anterior segments - apart from cataracts
  • Subjects with clear intraocular media other than cataract

Exclusion criteria

Exclusion Criteria:

  • Pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:

    • Microphthalmia
    • Corneal decompensation or Endothelial Insufficiency
    • Pseudo exfoliation
    • High myopia
    • Pars planitis
  • Patient with greater than 1 dioptre of pre-operative corneal astigmatism
  • Subjects who are expected to require retinal laser treatment
  • Previous intraocular and/or corneal surgery
  • History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
  • Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location
  • Subjects using a systemic medication that is known to cause ocular side effects
  • Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
  • Subjects who have only one eye with potentially good vision
  • Patients who are not willing to cooperate in the 6-months follow-up period
  • Children under the age of 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)

Interventions

  • DeviceVisual Acuity

    Assessment of visual acuity

  • DeviceContrast sensitivity

    Assessment of contrast sensitivity

  • DeviceReading Speed

    Assessment of reading speed

  • ProcedureEye Health

    Examination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure.

06

What researchers measure

Primary outcomes

  1. Visual acuity at distance and near

    Time frame: 1 year

Secondary outcomes

  1. Range of clear vision

    Time frame: 1 year

  2. Reading speed

    Time frame: 1 year

  3. Cntrast sensitivity

    Time frame: 1 year

07

Study locations

2 sites
  • Ruprecht- Karl Universitat Heidelberg
    Abteilung Augenheilkunde, Heidelberg 69120, Germany
  • Eye Clinic and national Centre of Ophthalmology
    Kaunas, LT-44307, Lithuania
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.

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

Registered
Aug 17, 2009
First posted
Aug 18, 2009
Start
Sep 2009
Primary completionActual
Aug 2011
CompletionActual
Aug 2011
Last update
Feb 8, 2013
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 Feb 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00960700
Lead sponsor
Rayner Intraocular Lenses Limited
Responsible party
Sponsor
First posted
Aug 18, 2009
Start date
Sep 2009
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Feb 8, 2013

Study contacts

Gerd U Auffarth, Prof.
principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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