A Multi Focal Visual Outcome Study Using Different Near Additions

February 7, 2013 updated by: Rayner Intraocular Lenses Limited

Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity at distance and near
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of clear vision
Time Frame: 1 year
1 year
Reading speed
Time Frame: 1 year
1 year
Cntrast sensitivity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rayner Intraocular Lenses Limited

Investigators

  • Principal Investigator: Gerd U Auffarth, Prof.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rayner-630F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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