Abstract
Purpose. To evaluate clinically and histologically the safety and biocompatibility of a new HDPE-based spherical porous orbital implants in rabbits. Methods. MEDPOR (Porex Surgical, Inc., Fairburn, GA, USA), OCULFIT I, and OCULFIT II (AJL Ophthalmic S.A., Vitoria, Spain) implants were implanted in eviscerated rabbis. Animals were randomly divided into 6 groups (n = 4 each) according to the 3 implant materials tested and 2 follow-up times of 90 or 180 days. Signs of regional pain and presence of eyelid swelling, conjunctival hyperemia, and amount of exudate were semiquantitatively evaluated. After animals sacrifice, the implants and surrounding ocular tissues were processed for histological staining and polarized light evaluation. Statistical study was performed by ANOVA and Kaplan-Meier analysis. Results. No statistically significant differences in regional pain, eyelid swelling, or conjunctival hyperemia were shown between implants and/or time points evaluated. However, amount of exudate differed, with OCULFIT I causing the smallest amount. No remarkable clinical complications were observed. Histological findings were similar in all three types of implants and agree with minor inflammatory response. Conclusions. OCULFIT ophthalmic tolerance and biocompatibility in rabbits were comparable to the clinically used MEDPOR. Clinical studies are needed to determine if OCULFIT is superior to the orbital implants commercially available.
Highlights
The first orbital implants were made of glass, plastic, cartilage, and silicone [1,2,3,4]
At 90 days after implantation, one animal in the MEDPOR group and one in the OCULFIT II group were lost to follow-up due to posterior paresis and subsequent ethical sacrifice
The socket of rabbits after evisceration of the globe is a widely and currently used model to adequately test intraocular implants [23,24,25]. In this experimental study in rabbits, we found that, at 90 and 180 days, the tolerance and biocompatibility of the OCULFIT implants was as good as the MEDPOR, an implant in current clinical use
Summary
The first orbital implants were made of glass, plastic, cartilage, and silicone [1,2,3,4]. Hydroxyapatite and porous polyethylene were first introduced as new implant materials in the 1980s and in the 1990s, respectively [6, 7]. These porous implants have been successfully used for improving prosthetic motility and have provided a more natural and cosmetically pleasing look for anophthalmic patients [8]. MEDPOR has pores greater than 150 μm, permitting the ingrowth of host vascular and soft tissue. This biointegration reduces the infection rates because it enables immune response to infection and allows delivery of systemically administered antibiotics [9, 10]. The use of these materials is accompanied by some complications, such as Journal of Ophthalmology
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