RESUMO
BACKGROUND: A new type of materials, Collamer, is polymerized with type V collagen and HEMA by Staar company, which is a good material for the establishment of intraocular contact lens(ICL). There is no similar material in our country.OBJECTIVE: To evaluate the biocompatibility of ICL made mainly by collagen-polymer in animals.DESIGN: A randomized controlled trial.SETTING: Testing Center of Shanghai Institute of Biomaterial.MATERIALS: Our study was conducted in the Testing Center of Shanghai Institute of Biomaterial from January 2000 to April 2000. Cell strain: hearty L-929 cells(fibroblast of mouse) after 48-72 hours of passage; Twenty white guinea pig of either gender aged between 1 month and 3 months with a body mass between 300 g and 500 g; Seven healthy adult New Zealand rabbit of either gender(female rabbits were not required pregnant for pyrogenic reaction test) with a body mass between 1.7 kg and 3.0 kg or between 2.5 kg and 3.5 kg(experimental animals were obtained from Shanghai experimental animal center, ordinary grade).INTERVENTIONS: Collagen was used to perform the following biological tests: ① cytotoxicity test (cell growth rate); ② anaphylaxis test; ③ pyrogenic reactions test; ④ subcutaneous implant test. The data were analyzed and evaluated according to criteria.MAIN OUTCOME MEASURES: ① Growth and proliferation of fibroblast in mice; ② Reactions of erythema and edema of every provocation site and every observatory time after the induction of intradermal injection and local patch test; ③ Increase of body temperature of the rabbit after the injection of the extraction of the material into auricle marginal vein; ④ Reactions around the materials after 4 weeks of collagen implantation in rabbits subcutaneously.RESULTS: ① Cytotoxicity test: relative growth rate of collagen group was 99％ to 106%, and the toxicity grade was level 0 - 1. ② Anaphylaxis test:there was no erythema or edema reaction at every provocation site at each time point of collagen group. The skin reaction to collagen-polymer was level 0. ③ Pyrogenic reactions test: the temperature increased in rabbit was below 0.6 ℃ and the total increase of the temperature was below 1.4 ℃ in rabbits. ④ Subcutaneous implant test: there was very little lymphocyte infiltration around the sample in both collagen group and control group with Level I inflammatory reaction. And the evaluation of the formation of fiber cyst was level I.CONCLUSION: Results of material biological evaluation tests demonstrate that this collagen-polymer has high biocompatibility, and can become an ideal material for ICL.
