Purpose: To test the viability of implanting the Artisan®/VerisyseTM lens in a low-income monocular aphakic African population with insufficient capsular support where contact lens wear is expensive and spectacle correction is not possible, by assessing the postoperative visual functions. To further assess whether adverse effects (e.g.: pigment dispersion with secondary glaucoma, prolonged uveitis) in patients with highly pigmented irises would be as low as with patients in European and American trials. Methods: A prospective, randomised, controlled clinical trial comparing outcomes in two groups of unilateral aphakic patients. The patients in the first group received an Artisan intra-ocular iris-claw lens as a secondary procedure while the second group remained aphakic (the current treatment status quo for public patients in KwaZulu-Natal province in South Africa). Follow-up was done for 1 year. Results: The study was terminated early due to ethical and statistical reasons. Nine treated and five control patients were included. Monocular uncorrected vision was significantly higher in the treatment group (P=0,012) and patient satisfaction was higher (p=0,002). Changes in other variables (intraocular pressure, angle pigmentation, change in cup-to-disc ratio, iris pigment changes and best spectacle corrected vision) were not significantly different between the two groups. Conclusion: The Artisan®/VerisyseTM lens is a feasible option for aphakic African patients with regard to visual outcome, safety and patient satisfaction. This form of refractive correction should be the standard for patients with no capsular support and where other options are too expensive or carry greater risk.

Thesis (M.Med.)-University of KwaZulu-Natal, Durban, 2007.