None listed
Conditions
Brief summary
Prospective randomised study is to assess the safety and efficacy of the two intraocular lens (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.
Interventions
The main objective of this prospective randomised study is to assess the safety and efficacy of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The Tecsoft IOL will be the intervention IOL and the comparator will be the Alcon IOL. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications. The patients will be followed for a one year period at intervals of 0-2 months before surgery, day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative. The benefit from the two IOL’s studied being equivalent is that the very significantly cheaper Tecsoft IOL could confidently be used in cataract surgery with IOL implantation saving the Australian community millions of health dollars that could more usefully be directed to fund other new and cost effective medical technology.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria: (i) Uncomplicated age-related cataract (ii) Males and females of at least 40 years of age. (iii) Must understand and provide written informed consent. (iv) Willing and able to return for scheduled postoperative follow-up examinations.
Exclusion criteria
Exclusion criteria: (i) History of/or clinical signs of anterior uveitis in either eye. (ii) Diabetic retinopathy in either eye. (iii) Glaucoma in either eye. (iv) Pseudoexfoliation. (v) Amblyopia in either eye. (vi) Blind in the fellow eye. (vii) Central Corneal Opacity/Fuch’s Dystrophy. (viii) Serious (i.e. life threatening) non-ophthalmic disease which may preclude study completion. (ix) Unwilling or unable to provide written informed consent.