Posters

Amniotic membrane from umbilical cord as scleral patch graft (SclerFIX): a single centre experience

Poster Details

First Author: S.Nahon-Estève FRANCE

Co Author(s):    C. Maschi   L. Barnouin   J. Caujolle              

Abstract Details

Purpose:

Umbilical cord lining (UCL) is composed of 2 layers: amnion and wharton’s jelly which is composed of collagen structure and small proteoglycans as sclera. To be use as graft, UCL undergoes a viral-inactivating, freeze-driyng and sterilizing patented treatment (tUCL). This devitalized, sterile scaffold of umbilical cord lining has biological properties similar than sclera and it makes it possible to hypothesize a regeneration of the tissue adapted in the management of the causes of thinning of tumor or inflammatory sclera.

Setting:

After in vivo animal study (16 rabbit trabeculectomies) with a comparison of UCL versus autograft until 45 days and an overall quality and kinetic of reconstruction of tUCL-implanted animals for scleral defect similar to autograft-operated animals. A clinical trial in scleral thinning after tumoral excision or irradiation is performed.

Methods:

Patients between 18 to 65 years with risk of scleral perforation (thinning after irradiation (IR), surgery (SG) or scleritis (S)), with a scleral defect (thickness > 50% compared to adjacent area and thinning surface less than 2 cm2) were included in one center, with an objective of more 80% of thickness improvement (compared to adjacent in OCT) obtained after 1 month and followed after 3 and 6 months. The safety of the surgery and the overall ocular surface with intraocular pressure were also followed at 15 days, 1, 3 and 6 months.

Results:

At date, 8 patients were included (2 IR, 6 SG after tumoral excision). One IR patient was withdrawn at day 15 for suture leakage. At day 15, edema (100%) and hyperemia (80%) were observed in the transplanted area but clinically integrated. The mean thickness was 87% compared to adjacent area (confidence interval 35-106%) at 1 month with a tissue density differenciation of the graft (OCT). Patients with tumor excision were treated by proton therapy after 1 month. After 3 months: tissue density of graft confirmed integration but differenciation, thickness little higher than adjancent surface (+6%).

Conclusions:

The preliminary of results are encouraging for regeneration of sclera with an quick integration before the irradiation and a tissue stability post irradiation.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented