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.

Mémoire numérisé par la Direction des bibliothèques de l'Université de Montréal.

Orientadores: Vital Paulino Costa, Carlos Eduardo Leite Arieta / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-08-23T19:38:14Z (GMT). No. of bitstreams: 1 MassaResende_Graziela_D.pdf: 3242400 bytes, checksum: e2f62de85f9ba384fc976b9263cd9197 (MD5) Previous issue date: 2013 / Resumo: O presente estudo tem como objetivos investigar a variação da espessura corneana central (ECC) e da pressão intraocular (PIO) em crianças após cirurgia de catarata congênita, bem como fatores de risco associados com essas mudanças. Vinte e seis crianças com catarata congênita foram recrutadas prospectivamente antes da cirurgia para remoção da mesma. Trinta e sete olhos foram analisados. Todos pacientes foram submetidos a exame oftalmológico completo com avaliação da PIO e da ECC antes da cirurgia e 6, 12, 18, 24 e 36 meses após o procedimento cirúrgico, pelo mesmo observador. A paquimetria ultrassônica foi realizada com o aparelho Ocuscan RXP (Alcon Laboratories Inc, USA), e a tonometria foi realizada com o tonômetro de aplanação de Goldmann modelo R900 (Haag-Streit, Koeniz, Suíça) ou tonômetro de aplanação de Perkins (Clement Clark International ltd, Londres, Inglaterra). Dos 37 olhos, 15 tornaram-se afácicos e 22, pseudofácicos. A ECC média aumentou significativamente de 556,24 ± 44,19 ?m para 585,07 ± 56,45 ?m (p = 0,025) ao final de três anos, enquanto a PIO média aumentou significativamente de 12,05 ± 2,3 mmHg para 13,96 ± 2,99 mmHg (p = 0,005). Olhos afácicos foram submetidos à cirurgia em uma idade mais precoce (15,16 ± 32,02 meses) em comparação aos olhos pseudofácicos (71,48 ± 53,14 meses) (p <0,001). Após três anos, a média de variação da ECC, nos olhos afácicos (56,10 ± 46,97 ?m), foi significativamente maior que nos olhos pseudofácicos (12,71 ± 38,41 ?m) (p = 0,015). Encontramos correlação negativa entre a idade no momento da cirurgia e a variação da ECC (r = -0,34, p = 0,04), mas não entre idade e variação da PIO (r = -0,18, p = 0,27). Quando a cirurgia foi realizada entre 0 e 1 ano de idade, a média de variação da ECC, em três anos, foi de 69,0 ± 40,3 ?m, em comparação com 1,0 ± 23,17, -20,0 ± 8,04 e 34,25 ± 40,11 ?m quando as cirurgias foram realizadas de 1 a 5, 5 a 10 e > 10 anos, respectivamente (p <0,001). Não houve correlação da variação da PIO com a variação da ECC (r = 0,31, p = 0,06). Concluímos que a ECC aumenta nos olhos submetidos à cirurgia de catarata congênita, especialmente quando a cirurgia é realizada em uma idade precoce / Abstract: The present study aims to investigate the variation of central corneal thickness (CCT) and intraocular pressure (IOP) in children after congenital cataract surgery, as well as risk factors associated with these changes. Twenty-six children with congenital cataract were prospectively recruited prior to surgery. Thirty-seven eyes were analyzed. All patients underwent a complete ophthalmic examination with assessment of IOP and CCT before surgery and 6, 12, 18, 24 and 36 months after surgery by the same observer. Ultrasonic pachymetry was performed with the handset unit Ocuscan RXP (Alcon Laboratories Inc, USA) and tonometry was performed with the Goldmann applanation tonometer model R900 (Haag-Streit, Koeniz, Switzerland) or the Perkins applanation tonometer (Clement Clark International Ltd, London, England). Among the 37 eyes, 15 became aphakic and 22 pseudophakic. The mean CCT increased significantly from 556.24 ± 44.19 ?m to 585.07 ± 56.45 ?m (p = 0.025) at the end of three years, while the mean IOP increased significantly from 12.05 ± 2.3 mmHg to 13, 96 mmHg ± 2.99 (p = 0.005). Aphakic eyes underwent surgery at an earlier age (15.16 ± 32.02 months) compared with pseudophakic eyes (71.48 ± 53.14 months) (p <0.001). After three years, the mean CCT change in aphakic eyes (56.10 ± 46.97 ?m) was significantly higher than in pseudophakic eyes (12.71 ± 38.41 ?m) (p = 0.015). Age at the time of surgery was inversely correlated to CCT change (r = -0.34, p= 0.04), but not to IOP change (r=-0.18, p= 0.27). When surgery was performed between 0 and 1 year of age, the mean CCT change in 3 years was 69.0 ± 40.03 ?m, compared with 1.0 ± 23.17, -20.0 ± 6.56 and 34.25 ± 40.11 ?m when the surgeries were performed between 1-5, 5-10 and > 10 years, respectively (p <0.001). There was no correlation between IOP change and CCT change (r = 0.31, p = 0.06). We conclude that CCT increases in eyes undergoing congenital cataract surgery, especially when the surgery is performed at an early age / Doutorado / Oftalmologia / Doutora em Ciências Médicas