A Multi Focal Visual Outcome Study Using Different Near Additions

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00960700

Enrollment

Registered

2009-08-18

Start date

2009-09-30

Completion date

2011-08-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Aphakia

Keywords

MFlex, Multifocal, 630F

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.

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Visual acuity at distance and near	1 year

Secondary

Measure	Time frame
Range of clear vision	1 year
Reading speed	1 year
Cntrast sensitivity	1 year

Countries

Germany, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026