Marios Constantinou1, Vishal Jhanji2, Xie Jing1, Ecosse L Lamoureux3, Umberto Boffa4, Hugh R Taylor5, Rasik B Vajpayee6. 1. Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia. 2. Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong. 3. Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia; Singapore Eye Research Institute, National University of Singapore, Singapore, Republic of Singapore. 4. BUPA, Hawthorn VIC, Australia. 5. Melbourne School of Population Health, University of Melbourne, Melbourne, Australia. 6. Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia; Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: rasikv@unimelb.edu.au.
Abstract
PURPOSE: To compare the outcomes of 2 intraocular lenses (IOLs) for the treatment of age-related cataracts. DESIGN: Prospective, randomized trial. PARTICIPANTS: Patients with age-related cataracts were recruited and randomized to receive phacoemulsification and implantation of either the AcrySof SA60AT lens (Alcon, Inc, Fort Worth, TX) or the low-cost Tecsoft Flex lens (Fred Hollows Foundation, Tilganga, Nepal). A total of 300 patients were available for description and analysis (148 in the AcrySof group and 152 in the Tecsoft group). METHODS: Patients underwent phacoemulsification and implantation of the AcrySof SA60AT lens or the Tecsoft Flex lens. They were followed up and examined at baseline, 1 week, 1 month, 6 months, and 12 months after cataract surgery. MAIN OUTCOME MEASURES: Uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), incidence of posterior capsule opacification (PCO), Visual Function Index questionnaire results, and safety of the implanted IOLs. RESULTS: No significant difference (P>0.05) was found in UDVA and BDVA after surgery between the 2 groups. The equivalence test of the 95% confidence intervals showed that both lenses had an equal improvement of UDVA and BDVA as well as similar rates of PCO after cataract surgery. There was no significant difference between the 2 groups with regard to visual functioning or the incidence of adverse surgical events during (P>0.05) or after (P>0.05) the surgery. CONCLUSIONS: The Tecsoft Flex IOL is a low-cost suitable alternative that is similar to the AcrySof IOL in terms of safety and visual outcomes.
RCT Entities:
PURPOSE: To compare the outcomes of 2 intraocular lenses (IOLs) for the treatment of age-related cataracts. DESIGN: Prospective, randomized trial. PARTICIPANTS: Patients with age-related cataracts were recruited and randomized to receive phacoemulsification and implantation of either the AcrySof SA60AT lens (Alcon, Inc, Fort Worth, TX) or the low-cost Tecsoft Flex lens (Fred Hollows Foundation, Tilganga, Nepal). A total of 300 patients were available for description and analysis (148 in the AcrySof group and 152 in the Tecsoft group). METHODS:Patients underwent phacoemulsification and implantation of the AcrySof SA60AT lens or the Tecsoft Flex lens. They were followed up and examined at baseline, 1 week, 1 month, 6 months, and 12 months after cataract surgery. MAIN OUTCOME MEASURES: Uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), incidence of posterior capsule opacification (PCO), Visual Function Index questionnaire results, and safety of the implanted IOLs. RESULTS: No significant difference (P>0.05) was found in UDVA and BDVA after surgery between the 2 groups. The equivalence test of the 95% confidence intervals showed that both lenses had an equal improvement of UDVA and BDVA as well as similar rates of PCO after cataract surgery. There was no significant difference between the 2 groups with regard to visual functioning or the incidence of adverse surgical events during (P>0.05) or after (P>0.05) the surgery. CONCLUSIONS: The Tecsoft Flex IOL is a low-cost suitable alternative that is similar to the AcrySof IOL in terms of safety and visual outcomes.