A Multi Focal Visual Outcome Study Using Different Near Additions

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00960700
• Other study ID #: Rayner-630F
• Status: Terminated
• Phase: N/A
• First received: August 17, 2009
• Last updated: February 7, 2013
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Rayner Intraocular Lenses Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• Visual Acuity
Assessment of visual acuity
• Contrast sensitivity
Assessment of contrast sensitivity
• Reading Speed
Assessment of reading speed

Procedure:
• Eye Health
Examination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure.

Locations

Country	Name	City	State
Germany	Ruprecht- Karl Universitat Heidelberg	Abteilung Augenheilkunde	Heidelberg
Lithuania	Eye Clinic and national Centre of Ophthalmology	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Rayner Intraocular Lenses Limited

Countries where clinical trial is conducted

Germany,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity at distance and near		1 year	No
Secondary	Range of clear vision		1 year	No
Secondary	Reading speed		1 year	No
Secondary	Cntrast sensitivity		1 year	No

External Links

•   Publication from the results