The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning.
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
Hôpital Pasteur 2 - CHU de NICE
Nice, France
Rate of tectonic success of the graft at 3 months
The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface \> 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).
Time frame: 3 months
Absence of inflammatory reactions and good local tolerance of the implant
Composite score evaluating the presence of local reactions (edema, redness, vascularization, discharge) and of ulceration, pain and foreign body sensation (0: excellent local tolerance, 46: worst possible local tolerance)
Time frame: 15 days, 1 month, 3 months
Evaluation of the visual acuity
Scoring of blurred and poor vision (0: never, 4: all the time)
Time frame: 15 days, 1 month, 3 months
Evaluation of the eye pressure
Measure of eye pressure using a tonometer
Time frame: 15 days, 1 month, 3 months
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