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In vivo biocompatibility assessment of (PTFE-PVDF-PP) terpolymer-based membrane with potential application for glaucoma treatment.

Leszczynski R, Stodolak E, Wieczorek J, Orlowska-Heitzman J, Gumula T, Blazewicz S - J Mater Sci Mater Med (2010)

Bottom Line: The clinical observations were made after 14 and 30 days.During the study clinical symptoms of a moderate degree were observed, and histopathological changes were typical for foreign body implantation.At the end stage of the study no significant difference in histopathological assessment was found between control and experimental group.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Medical University of Silesia, Katowice, Poland.

ABSTRACT
The aim of the work was to evaluate the in vivo biological behaviour of polymeric membrane materials for glaucoma implants. The base material was biostable synthetic terpolymer (PTFE-PVDF-PP) with proved biocompability (PN-EN ISO 10993). The samples manufactured in the form a membrane were subjected to chemical and physical treatment to create an open pore system within the polymer matrix. As a porogenic phase biodegradable natrium alginate in a fibrous form was employed. The non-perforating deep sclerectomy technique was performed in a rabbit model. The clinical observations were made after 14 and 30 days. During the study clinical symptoms of a moderate degree were observed, and histopathological changes were typical for foreign body implantation. At the end stage of the study no significant difference in histopathological assessment was found between control and experimental group. Similarities observed in both groups and relatively mild histopathological changes in the tissue surrounding the implant indicate that the observed symptoms come from a deep scleral trauma caused by surgery, and not by the presence of the implant itself.

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Histopathological evaluation of removed eyeballs: a 14th day without implant—congestion of sclera, with focal areas of resorption granular tissue, formed in nodules, localized around surgical suture; b 14th day with implant: the implant in central part surrounded by an abundant granular tissue; c 1 month without implant—abundant granular tissue; d 1 month with implant—the implant visible in the central part surrounded by unspecific partially resorption granular tissue, resorption granular tissue can be seen also sub conjunctivally, oedema of cillary body
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Fig2: Histopathological evaluation of removed eyeballs: a 14th day without implant—congestion of sclera, with focal areas of resorption granular tissue, formed in nodules, localized around surgical suture; b 14th day with implant: the implant in central part surrounded by an abundant granular tissue; c 1 month without implant—abundant granular tissue; d 1 month with implant—the implant visible in the central part surrounded by unspecific partially resorption granular tissue, resorption granular tissue can be seen also sub conjunctivally, oedema of cillary body

Mentions: Results of histopathological evaluation of removed eyeballs are gathered in Table 2 and Fig. 2. On histopathological evaluation, an increase of amount of resorption granulation was the only reaction observed around the implant, defined as not matured connective tissue, which is always present in case of tissue destruction. Multinucleated histocytes, phagocyting, removing altered tissue and foreign bodies are typical features of this tissue. After 14 days, a moderate amount of granulation was observed in one eyeball, and after 30 days a high amount of granulation was present in three eyeballs. The observed difference inside the sclera related to both times of observation was statistically significant, at P ≤ 0.05 (Table 2). In spite of scleral dissection with chronic inflammatory, inflammation could also be seen. In eyeballs with the inserted implants only granulation was present. After follow up of 14 days in one eyeball a high amount of granulation tissue was found. In one eyeball of the control group after 14 days a high amount of granulation tissue was present, and after 30 days a moderate amount of granulation in two eyeballs was noticed. In the ciliary body there was a high amount of granulation in one eyeball with the implant and a small amount of granulation in the other one after 14 and 30 days, respectively. Moreover, in one eyeball a moderate inflammation on days 14 and 30 was observed. In control only a mild to moderate stromal oedema was observed in the ciliary body, without any features of histopathological lesions. The difference between both groups was statistically significant (Table 2). In the group with the implants, 14 days after surgery a small amount of granular tissue was observed subconjunctivally in two eyeballs; in some eyeballs a mild inflammation with focal sclerosis and hyalinization was observed in this area. In control group focal fibrosis and hyalinization of a moderate degree was observed subconjunctivally in one eyeball. After 1 month, no subconjunctival changes were found on histopathological evaluation in any of the analyzed groups. Additionally, in few eyeballs moderate or severe haemorrhages were noticed on day 14 in study and control group. A mild and moderate fibrosis was found in two eyeballs in control group. After 1 month, an abundant connective tissue and moderate number of thin-walled vessels created in both groups; additionally, in one eyeball of the study group small single haemorrhages and congestion were observed. On days 14 and 30, in one eyeball in control group a purulent inflammatory infiltration, consisting mainly of granulocytes, was found. No purulent infiltration was observed in group with the implant.Table 2


In vivo biocompatibility assessment of (PTFE-PVDF-PP) terpolymer-based membrane with potential application for glaucoma treatment.

Leszczynski R, Stodolak E, Wieczorek J, Orlowska-Heitzman J, Gumula T, Blazewicz S - J Mater Sci Mater Med (2010)

Histopathological evaluation of removed eyeballs: a 14th day without implant—congestion of sclera, with focal areas of resorption granular tissue, formed in nodules, localized around surgical suture; b 14th day with implant: the implant in central part surrounded by an abundant granular tissue; c 1 month without implant—abundant granular tissue; d 1 month with implant—the implant visible in the central part surrounded by unspecific partially resorption granular tissue, resorption granular tissue can be seen also sub conjunctivally, oedema of cillary body
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC2962782&req=5

Fig2: Histopathological evaluation of removed eyeballs: a 14th day without implant—congestion of sclera, with focal areas of resorption granular tissue, formed in nodules, localized around surgical suture; b 14th day with implant: the implant in central part surrounded by an abundant granular tissue; c 1 month without implant—abundant granular tissue; d 1 month with implant—the implant visible in the central part surrounded by unspecific partially resorption granular tissue, resorption granular tissue can be seen also sub conjunctivally, oedema of cillary body
Mentions: Results of histopathological evaluation of removed eyeballs are gathered in Table 2 and Fig. 2. On histopathological evaluation, an increase of amount of resorption granulation was the only reaction observed around the implant, defined as not matured connective tissue, which is always present in case of tissue destruction. Multinucleated histocytes, phagocyting, removing altered tissue and foreign bodies are typical features of this tissue. After 14 days, a moderate amount of granulation was observed in one eyeball, and after 30 days a high amount of granulation was present in three eyeballs. The observed difference inside the sclera related to both times of observation was statistically significant, at P ≤ 0.05 (Table 2). In spite of scleral dissection with chronic inflammatory, inflammation could also be seen. In eyeballs with the inserted implants only granulation was present. After follow up of 14 days in one eyeball a high amount of granulation tissue was found. In one eyeball of the control group after 14 days a high amount of granulation tissue was present, and after 30 days a moderate amount of granulation in two eyeballs was noticed. In the ciliary body there was a high amount of granulation in one eyeball with the implant and a small amount of granulation in the other one after 14 and 30 days, respectively. Moreover, in one eyeball a moderate inflammation on days 14 and 30 was observed. In control only a mild to moderate stromal oedema was observed in the ciliary body, without any features of histopathological lesions. The difference between both groups was statistically significant (Table 2). In the group with the implants, 14 days after surgery a small amount of granular tissue was observed subconjunctivally in two eyeballs; in some eyeballs a mild inflammation with focal sclerosis and hyalinization was observed in this area. In control group focal fibrosis and hyalinization of a moderate degree was observed subconjunctivally in one eyeball. After 1 month, no subconjunctival changes were found on histopathological evaluation in any of the analyzed groups. Additionally, in few eyeballs moderate or severe haemorrhages were noticed on day 14 in study and control group. A mild and moderate fibrosis was found in two eyeballs in control group. After 1 month, an abundant connective tissue and moderate number of thin-walled vessels created in both groups; additionally, in one eyeball of the study group small single haemorrhages and congestion were observed. On days 14 and 30, in one eyeball in control group a purulent inflammatory infiltration, consisting mainly of granulocytes, was found. No purulent infiltration was observed in group with the implant.Table 2

Bottom Line: The clinical observations were made after 14 and 30 days.During the study clinical symptoms of a moderate degree were observed, and histopathological changes were typical for foreign body implantation.At the end stage of the study no significant difference in histopathological assessment was found between control and experimental group.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Medical University of Silesia, Katowice, Poland.

ABSTRACT
The aim of the work was to evaluate the in vivo biological behaviour of polymeric membrane materials for glaucoma implants. The base material was biostable synthetic terpolymer (PTFE-PVDF-PP) with proved biocompability (PN-EN ISO 10993). The samples manufactured in the form a membrane were subjected to chemical and physical treatment to create an open pore system within the polymer matrix. As a porogenic phase biodegradable natrium alginate in a fibrous form was employed. The non-perforating deep sclerectomy technique was performed in a rabbit model. The clinical observations were made after 14 and 30 days. During the study clinical symptoms of a moderate degree were observed, and histopathological changes were typical for foreign body implantation. At the end stage of the study no significant difference in histopathological assessment was found between control and experimental group. Similarities observed in both groups and relatively mild histopathological changes in the tissue surrounding the implant indicate that the observed symptoms come from a deep scleral trauma caused by surgery, and not by the presence of the implant itself.

Show MeSH
Related in: MedlinePlus