A Multi Focal Visual Outcome Study Using Different Near Additions

Sponsor

Rayner Intraocular Lenses Limited (Industry)

Overall Status

Terminated

CT.gov ID

NCT00960700

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Aphakia	Device: Visual Acuity Device: Contrast sensitivity Device: Reading Speed Procedure: Eye Health

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Outcome Measures

Primary Outcome Measures

Visual acuity at distance and near [1 year]

Secondary Outcome Measures

Range of clear vision [1 year]
Reading speed [1 year]
Cntrast sensitivity [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruprecht- Karl Universitat Heidelberg	Abteilung Augenheilkunde	Heidelberg	Germany	69120
2	Eye Clinic and national Centre of Ophthalmology	Kaunas		Lithuania	LT-44307