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

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

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