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AniCell Biotech, LLC Research Study

Summer 2020

Principal Investigators

• Robert Peiffer
• Heather Brookshire
• Jens Fritsche
• Thomas Dulaurent
• Susan Carastro
• Elizabeth Lutz

 

Study Information

• Study Duration: August 1-December 31, 2020
• Case Numbers: estimate 4-5 cases per PI
• Publication: Submission to Veterinary Ophthalmology or another online quick access journal
• Study Links: https://anicellbiotech.com/ophtho-app

https://anicellbiotech.com/ophtho-followup

 

Title

Examination of Accelerated Healing Properties of Amnion Membrane Transplantation for Ocular Surface Disease in Canine and Feline Patients – Observational Case Series Study

 

Hypothesis

• Dogs and cats with the ocular surface disease treated with amnion post keratectomy or trauma will heal faster than the average of surgical candidates managed traditionally without applied amnion.

The mechanism involves the release of soluble chemokines by the membrane which hydrolyzes over several days. It does not provide structural support nor a scaffold for fibrosis and its application may require the combined use of an autologous tissue or biosynthetic graft, a third eyelid flap, or a temporary tarsorrhaphy. These ancillary procedures should be described in the protocol

Aim of the study:

• Evaluate the use of dehydrated amniotic membrane (Anicell) in the management of ocular surface disease in dogs and cats

 

Study design:

• Multicenter prospective study
• Inclusion examples: Includes Epibulbar Melanoma (EM) in dogs, Symblepharon in cats, Ulcerative Keratitis, Feline Corneal Sequestrum (FCS), Limbal Dermoids, conjunctival defects, tumor excision, lid reconstruction, and any other ocular surface-related diseases where amnion application may be warranted.
• Exclusion criteria: The mechanism of action for amnion is inflammation.  The use of any drug that suppresses inflammation would be contra-indicated. Animals with conditions that must be administered and cannot be weened off of NSAIDs or corticosteroids would be excluded from the study.  Animals with conditions such as chronic pervasive skin allergies, osteoarthritis, or other inflammatory conditions should consult Dr. Peiffer or Brandon Ames prior to admittance to the study.  A dog with Hyperadrenocorticism or high levels of inflammation may not be the best subject for this study.  Please use clinical judgment when selecting cases, keeping in mind that NSAIDs and corticosteroids are contraindicated with amnion application.

 

Materials:

• Patients presented with various types of ocular surface disease, including those requiring surgical intervention.
• Product Type: single-layer dehydrated amnion membrane (CanisCell AniOcular)

Methods:

• Surgery
  • Analgesia, anesthesia, preparation at surgeon’s discretion, but detailed
  • For cases of EM: if indicated Incisional or excisional biopsy with a 1 mm margin around the lesion, noting depth.
  • Single-layer of amniotic membrane applied and held in place with third eyelid flap.
  • Additional procedures (i.e. tarsorrhaphy, Hotz Celsius for the treatment of associated entropion) to be described

 

• Post-Operative Medical Treatment
  • At the discretion of the surgeon but detailed. Note: Topical and/or systemic corticosteroids AND NSAIDs are contraindicated with amniotic membranes
  • Antibiotics either topical and/or systemic at the discretion of the surgeon

Examination Timepoints & Data Collection

• Baseline (D0), 7, 14, 28, & 42 days

Data Collection Metrics

• Date of examination/procedure
• Signalment
  • breed, gender (intact/neutered) age, affected eye.
• History
  • Duration of lesion
  • Diagnoses
  • Prior diagnostics, (i.e. histopathology)
  • Prior to medical (topical and/or systemic) management and duration or surgical management
  • Pathogenesis of lesion (if known)
  • Infected/non-infected based on the presence or absence of infiltrate or cytology
  • Presence or absence of keratomalacia
  • Associated historical or contemporary ocular /adnexal disease
  • Other pertinent medical histories/information
• Clinical Measurements/Descriptions
  • Record location of lesion
  • lesion extent- measurements (length & width in mm; depth (superficial, deep, perforating) at each evaluation
    • The extent of the surface involved – (baseline measurement) and % improvement/healing at each evaluation time will be calculated. Corneal healing time in days will also be determined from this data.
  • Grade vascularization level (mild, moderate, severe) & depth (superficial, partial thickness, deep)
  • Grade associated uveitis if present (mild, moderate, severe)
  • Evaluation of transparency of healed corneal tissue (opaque, translucent, transparent)
• Images at each evaluation
• Additional procedures
• Alterations in the medical regimen overtime – detail
• Adverse events/complications
  • spread of underlying infection to the adjacent cornea or anterior chamber
  • failure of the amnion to be retained
  • post-op infections
  • post-op calcifications
  • dissolution or displacement requiring replacement of amnion required
  • progression of corneal disease despite the application of amnion
  • Disasters should be accompanied by tissue submission if possible
• Diagnostic Options
  • Cytological Evaluation (with cytobrush to characterize inflammation) on days 7, 14, and 28
  • On day 42: Snip/shave biopsy/histopathology of healed tissue (submitted flattened on a cellulose sponge and immersed in 10% formalin) to evaluate the quality and extent of conjunctival/corneal regeneration
  • Ultrasound Biomicroscopy (UBM) – high-resolution imaging of corneal structure
  • Optical Coherence Tomography (OCT) – high-resolution cross-sectional images of the cornea
  • Bacterial culture and sensitivity
  • PCR (for FHV 1 if applicable)