Purpose:To determine the effect of highly active antiretroviral therapy(HAART)on the natural history of ocular manifestations in HIV-infected children.Methods:All of the HIV-infected children attending the Institute of Pediatrics,University of Milan,Milan,Italy,between 1982 and 2004 were studied.Every 3 months,they were physically examined and underwent indirect fundoscopy conducted by an experienced ophthalmologist;if diagnosed as having eye disease,they were evaluated by the ophthalmologist every week while on specific therapy and monthly thereafter.The clinical and laboratory findings before and after the introduction of HAART were compared.Results:The cohort consisted of 117 HIV-infected children(61 males),with a follow-up ranging from 0.09 to 22.31 years(median,16.33 years).A total of nine cases of ocular involvement(7.7%)were diagnosed between 1983 and 1994,before the introduction of HAART.All nine children died 4-24 months(median,15 months)after the diagnosis of ophthalmic disease.No case of ocular involvement was observed after the introduction of HAART(P=0.011 vs before HAART).Conclusion:The introduction of HAART has had a significant impact on the natural history of ocular manifestations in HIV-infected children,thus suggesting that a reduction in the frequency of ophthalmologic follow-up should be considered for HAART treated HIV-infected children with immune reconstitution and no visual symptom. Purpose: To determine the effect of highly active antiretroviral therapy (HAART) on the natural history of ocular manifestations in HIV-infected children. Methods: All of the HIV-infected children attending the Institute of Pediatrics, University of Milan, Milan, Italy, Between 1982 and 2004 were studied. Everyvery while 3 months, they were physically examined and underwent indirect fundoscopy conducted by an experienced ophthalmologist; if diagnosed as having eye disease, they were evaluated by the ophthalmologist every week while on specific therapy and monthly thereafter. and laboratory findings before and after the introduction of HAART were compared. Results: The cohort consisted of 117 HIV-infected children (61 males) with a follow-up ranging from 0.09 to 22.31 years (median, 16.33 years). A total of nine cases of ocular involvement (7.7%) were diagnosed between 1983 and 1994, before the introduction of HAART. All nine children died 4-24 months (median, 15 months) after the diagnosis of ophthalmic disea The case of ocular involvement was observed after introduction of HAART (P = 0.011 vs before HAART). Conlusion: The introduction of HAART has had a significant impact on the natural history of ocular manifestations in HIV-infected children, thus suggesting that a reduction in the frequency of ophthalmologic follow-up should be considered for HAART treated HIV-infected children with immune reconstitution and no visual symptom.