title: Evaluation of intraocular reactivity to organic contaminants of ophthalmic devices in a rabbit model.
abstract: OBJECTIVE
  To evaluate the intraocular reactivity to organic contaminants of ophthalmic devices in the rabbit.
  
  
  METHODS
  Experimental animal study.
  
  
  METHODS
  Fifty New Zealand white rabbits.
  
  
  METHODS
  The rabbits were allocated to 10 groups of 5 each to receive 2 different doses of human albumin and nonhuman nucleic acids and their respective vehicle controls, a denatured cohesive ophthalmic viscosurgical device (OVD) and a denatured dispersive OVD and their respective nondenatured controls. All 10 eyes in each treatment group received bilateral intracameral injection of the test materials. All the eyes in the study were examined by slit-lamp biomicroscopy at baseline and 6, 9, 24, 48, and 72 hours. Pachymetry was also performed on eyes exposed to albumin, protein vehicle control, and the OVDs at these time points.
  
  
  METHODS
  Corneal thickness, grade of corneal clouding, anterior chamber (AC), cells, flare and fibrin, iridal hyperemia, cell and fibrin on lens surface, and onset time.
  
  
  RESULTS
  There were no inflammatory signs in any eyes exposed to human albumin. Anterior chamber cells (1+ to 3+) and flare and fibrin (1+ to 2+), along with cells and fibrin on the lens surface, were seen in the eyes exposed to the nucleic acid samples, and they resolved in 24 hours. Mild (mostly 1+) conjunctival congestion, cells, flare, and fibrin were seen in a few eyes exposed to the 2 denatured OVDs and their controls, with the response durations being shorter in the denatured OVD eyes (24 hours) than in the nondenatured OVD eyes (48 hours). Anterior chamber inflammation was generally observed in fewer denatured OVD eyes than in nondenatured OVD eyes, particularly the dispersive OVD eyes.
  
  
  CONCLUSIONS
  Intracameral injection of human albumin protein did not cause ocular inflammation. Nucleic acid intracamerally injected into rabbit eyes caused acute inflammation that quickly resolved. Cohesive and dispersive OVD denatured by drying and steam sterilization alone did not cause ocular inflammation.
authors.affiliation: Food and Drug Administration Oak Ridge Institute for Science and Education contractor, Silver Spring, Maryland 20993-0002, USA.
authors.forename: Shelley Y
authors.initials: SY
authors.lastname: Buchen
authors.forename: Don
authors.initials: D
authors.lastname: Calogero
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Tarver
authors.forename: Gene
authors.initials: G
authors.lastname: Hilmantel
authors.forename: Xing
authors.initials: X
authors.lastname: Tang
authors.forename: Malvina B
authors.initials: MB
authors.lastname: Eydelman
mesh_terms: D000418:Albumins / Q000633:toxicity*; D000818:Animals; D000869:Anterior Eye Segment / Q000187:drug effects*; D004247:DNA / Q000633:toxicity*; D004866:Equipment Contamination; D023421:Models, Animal; D009930:Organic Chemicals / Q000633:toxicity; D012329:RNA, Bacterial / Q000633:toxicity*; D011817:Rabbits; D014606:Uveitis, Anterior / Q000139:chemically induced*
chemical_list: D000418:Albumins; D009930:Organic Chemicals; D012329:RNA, Bacterial; D004247:DNA