A Multi Focal Visual Outcome Study Using Different Near Additions

Terminated

• Conditions: Cataract; Aphakia

• Registration Number: NCT00960700
• Lead Sponsor: Rayner Intraocular Lenses Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Study Start: 2009-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity at distance and near	1 year

Secondary Outcome Measures

Name	Time	Method
Range of clear vision	1 year
Reading speed	1 year
Cntrast sensitivity	1 year

Trial Locations

Locations (2)

Eye Clinic and national Centre of Ophthalmology; 🇱🇹 Kaunas, Lithuania

Ruprecht- Karl Universitat Heidelberg; 🇩🇪 Abteilung Augenheilkunde, Heidelberg, Germany