Status:
TERMINATED
A Multi Focal Visual Outcome Study Using Different Near Additions
Lead Sponsor:
Rayner Intraocular Lenses Limited
Conditions:
Cataract
Aphakia
Eligibility:
All Genders
18+ years
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00960700
Start Date
September 1 2009
End Date
August 1 2011
Last Update
February 8 2013
Active Locations (2)
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1
Ruprecht- Karl Universitat Heidelberg
Abteilung Augenheilkunde, Heidelberg, Germany, 69120
2
Eye Clinic and national Centre of Ophthalmology
Kaunas, Lithuania, LT-44307