NCT00960700

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

August 17, 2009

Last Update Submit

February 7, 2013

Conditions

CataractAphakia

Keywords

MFlexMultifocal630F

Outcome Measures

Primary Outcomes (1)

  • Visual acuity at distance and near

    1 year

Secondary Outcomes (3)

  • Range of clear vision

    1 year

  • Reading speed

    1 year

  • Cntrast sensitivity

    1 year

Interventions

Visual AcuityDEVICE

Assessment of visual acuity

Contrast sensitivityDEVICE

Assessment of contrast sensitivity

Reading SpeedDEVICE

Assessment of reading speed

Eye HealthPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruprecht- Karl Universitat Heidelberg

Abteilung Augenheilkunde, Heidelberg, 69120, Germany

Location

Eye Clinic and national Centre of Ophthalmology

Kaunas, LT-44307, Lithuania

Location

Related Links

MeSH Terms

Conditions

CataractAphakia

Interventions

Visual AcuityContrast Sensitivity

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological Phenomena

Study Officials

  • Gerd U Auffarth, Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

DE(1)LI(1)