Authors' objectives:

1) To compare the technical features of the intraocular lenses (IOL) specified on the marketing material of the products marketed by different providers in Catalonia during the period 1994-95;

2) to analyse, by means of the systematic review of the scientific evidence, if the differences observed may influence the clinical outcomes in the design of this type ofproducts.

Authors' results and conclusions: (1) The IOL is implanted after the crystalline lens is extracted, due to a cataract. (2) The available scientific evidence has shown that the different materials used in the composition of the IOLs reach an acceptable degree of safety, as regards both biocompatibility and other secondary complications. Visual acuity obtained after the implantation is also satisfactory. The highest clinical experience was with PMMA IOLs since they were the first to be introduced in the market. However, soft IOLs seem to have higher potential advantages,which need to validated in future studies. (3) In each different material group no study has been identified showing significant differences in the post-implantation clinical outcome among the marketed IOLs. (4) A total of 8 PMMA IOLs (Alcon CP10BG, AMEVISA RAYNER 604A, AMEVISA RAYNER 208U, BRAUN S. COBURN 68UV, CORNEAL CP60NS, CORNEAL DUAL 60, CORNEAL IV6, DOMILENS FLEX60) and 2 made of other materials (CORNEAL SPFLEX, CORNEAL HPFLEX) are compliant with the optimal or desirable characteristics for posterior chamber IOLs (i.e. total length between 12 and 14mm, diameter of the optical zone 6mm, biconvex, planoconvex or quiconvex shape and minimal power equal or less than 0 diopters). Also 10 anterior chamber IOLs have been identified as being close to the ideal characteristics (BRAUN S COBURN 121UV (TL=13.75mm), BRAUN S. COBURN 121UV (TL=12.5mm), CORNEAL AJPR, F. SCHMIDT MKVK400, GOPT IOLTECH PH55B, INDO A135, M. V. BIOTECH A60125, M. V. BIOTECH A60135, PHARMACIA 352C) (5) The main analysis parameter when purchasing this type of implant should be the availability of a product register number given by the Ministry of Health. Other parameters of interest are discussed in the document.

Project Status: Completed

URL for project: http://www.gencat.net/salut/depsan/units/aatrm/html/en/dir393/doc7921.ht ml

Year Published: 1996

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Qualitat i Avaluacio Sanitries de Catalunya

Contact Address: Antoni Parada, CAHTA, Roc Boronat, 81-95 (2nd floor), 08005 Barcelona, Spain, Tel. +34 935 513 928, Fax: +34 935 517 510

Contact Name: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Contact Email: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Copyright: Catalan Agency for Health Technology Assessment and Research