A Multi Focal Visual Outcome Study Using Different Near Additions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Cataract Aphakia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Visual Acuity

Assessment of visual acuity

Intervention Type DEVICE

Contrast sensitivity

Assessment of contrast sensitivity

Intervention Type DEVICE

Reading Speed

Assessment of reading speed

Intervention Type DEVICE

Eye Health

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No