Clinical trial NCT00960700: A Multi Focal Visual Outcome Study Using Different Near Additions
Official title: Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Aphakia
Keywords: MFlex
Multifocal
630F
Lead sponsor: Rayner Intraocular Lenses Limited
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual acuity at distance and near
timeFrame: 1 year
Secondary outcomes:
measure: Range of clear vision
timeFrame: 1 year
measure: Reading speed
timeFrame: 1 year
measure: Cntrast sensitivity
timeFrame: 1 year
Other outcomes:
Locations:
city: Abteilung Augenheilkunde
country: Germany
facility: Ruprecht- Karl Universitat Heidelberg
state: Heidelberg
city: Kaunas
country: Lithuania
facility: Eye Clinic and national Centre of Ophthalmology
Study officials:
name: Gerd U Auffarth, Prof.
role: PRINCIPAL_INVESTIGATOR
References: