Study: NCT01996826

Adverse event: Atrial fibrillation (subject was hospitalized for 3 days)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Urinary Track Infection (subject hospitalized for 3 days)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: AC cells in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Acute graft edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Allergic reaction to Bacitracin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Blurred vision (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Blurry vision (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 39 at risk

Adverse event: Broken sutures (2 broken sutures)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Central epithelial defect in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cloudy vision in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Corneal edema (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ulcerative keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Decrease in vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Difficulty seeing (OU)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Difficulty/pain with walking caused by recent arthritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Discomfort with tearing and burning
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Double vision (OU)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 39 at risk

Adverse event: Ear wax in the ear causing pain in the ear and face
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 39 at risk

Adverse event: High intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 39 at risk

Adverse event: Epithelial defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Foreign body sensation
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 39 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headaches due to ocular pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Herpes keratitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: High blood pressure
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Increase in the frequency of stinging when instilling eye drops
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Itchy eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 39 at risk

Adverse event: Light sensitivity in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mild edema in graft
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 39 at risk

Adverse event: Patient was hospitalized for urinary track infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Patient went to ER for bronchitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 39 at risk

Adverse event: Post-operative ocular pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative mild graft edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative AC cells
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Post-operative stromal edema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 39 at risk

Adverse event: Post-operative mild irritation and soreness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative aching/burning in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative light sensitivity (OU)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative low Intaocular Pressure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Post-operative iritis (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Possible rejection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Punctate epithelial erosions (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Retained lens cortex inferior (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Recurrent herpes keratitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Severe ocular pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Stromal edema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Stinging upon instillation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: bruised eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: scraped leg which became infected and resulted in debridement on July 20th.
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Transplant failure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: eye feeling heavier/tighter than usual
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: new scrape on leg
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Subject visited podiatrist as toenail was falling off
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: fungal infection in the OD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: "ping or a pluck" sensation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: pain behind non-study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: increase in leg cramps
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: left pupil appears to be smaller than right
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 39 at risk

Adverse event: Trichiatic lashes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Wound leak
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ocular burning upon instilling ophthalmic medication (Pred Forte and Vigamox)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ocular discomfort (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Ocular discomfort when closing eyelids tightly (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: congestive heart failure (subject hospitalized)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: a stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: AC cells in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: AC cells (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Acanthamoeba infection in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Allergic reaction to medications prescribed for congestive heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blurred vision (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blurry vision (OS)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Blurry vision (OU)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blurry vision in study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Burning in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Central scotoma in OD (non-study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Corneal infiltrate near the suture
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Corneal transplant
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ulcerative keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dark spot in central vision upon awakening each morning
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Darkening of vision (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Decrease in vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Decrease in vision following intravitreal injection of Eylea
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Descement's folds (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dimming of vision (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diplopia & glare at night when driving (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dry eye from allergies in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: High intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Low intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Endothelial (Khodadoust) rejection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Epithelial defect
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Flashes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Floaters following a clinical laser procedure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Floater following intravitreal injection of Eylea
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Foreign body sensation
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 36 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Green discharge in operative eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: High blood pressure
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hospitalization for shortness of breath with logs of edema in legs and fluid in lungs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Infection from scleral lenses in non-study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Irregular heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Itchy eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Left periocular trauma with an electrical cord plug. No injury to the eye. No symptoms. Subject feel
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye lid pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Mild irritation in the operative eye following a Lucentis injection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Mild ptosis (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Obscured vision in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 36 at risk

Adverse event: Ocular ache/pain in outer corner of non-study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular pain the night of the surgery
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular redness
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 36 at risk

Adverse event: Post-operative ocular pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Post-operative mild graft edema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Post-operative AC cells
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Post-operative stromal edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative high intraocular pressure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative aching/burning in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative epithelial defect
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Post-operative tearing
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Post-operative edema (3+)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative wound leak at clock hour 4
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative acid reflux
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative diffuse graft edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Post-operative increase in mucus in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Posterior Capsular Opacity (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ring of pink around the eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Retinal tear following a clinical laser procedure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Severe ocular pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Stromal edema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Shortness of breath and swelling in leg
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: increase in back pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: fever/flu with redness in eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: flashes of light
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: black strips in vision non-study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: hand surgery on his right hand
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: open blister on leg, which subject attributes to the CHF
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sub-epithelial infiltrates
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: vertigo, light-headedness, and slight nausea
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: seeing rust colors when looking at lights
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Superior neurocystic edema (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 36 at risk

Adverse event: Tenderness (OS)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Trichiatic lashes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Visual disturbances following a clinical laser procedure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular burning upon using eye drops in study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ocular eye irritation (OD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk