Phase 2 N=117 Traumatic Optic Neuropathy Treatment Trial (TONTT)
Traumatic Optic Neuropathy
Primary: Number of Participants With Change/Improvement Visual Acuity From the Beseline — 28; 3; 5 Participants
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Phase 2 N=22 Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Non-arteritic Ischemic Optic Neuropathy · Optic Nerve Injuries
Primary: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit — 15; 7; 9; 6 EDTRS Letters
N/A N=22 Trial of Alternating Current Stimulation in Optic Neuropathy
Optic Nerve Diseases · Optic Nerve Injuries · Optic Neuropathies
Primary: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors — 24.75; 39.16 percent change
N/A N=50 Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma
Head Trauma
Primary: Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients — 4.71; 5.19; 5.26 Milimeter
Phase 1 N=2 Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy
Nonarteritic Anterior Ischemic Optic Neuropathy
Primary: Change in Visual Acuity — 4; 3 lines change in Snellen chart
N/A N=40 Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Non-arteritic Ischemic Optic Neuropathy
Primary: Change From Baseline in Visual Acuity at 9 Month — -0.0574; 0.0535 LogMAR
N/A N=100 Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
Eye Injury Trauma
Primary: Corneal Thickness — 542.23; 546.16; 544.32 microns
N/A N=100 Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion
Elevated Intracranial Pressure (ICP)
Primary: Changes in ONSD in mm With Changes in ICP in Healthy Volunteers. — 4.2 mm
Phase 2 N=122 Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
Severe Traumatic Brain Injury
Primary: Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg . — 0.15; 0.44 Proportion
N/A N=26 Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
Traumatic Brain Injury
Primary: Stability of Fixation — 0.8; 1.1 degrees
Phase 2 N=82 BIIB033 In Acute Optic Neuritis (AON)
Acute Optic Neuritis
Primary: Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population — 20.83; 17.34 msec — p=0.3337
Phase 2 N=70 Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Glaucoma, Open-Angle
Primary: Percentage of Patients With a Visual Field Improvement in the Study Eye — 12.0; 9.5; 4.2 Percentage of Patients
Phase 3 N=44 A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
Optic Neuritis
Primary: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 — 128.1; 130.5; 89.5; 88.0 µm
N/A N=21,283 Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Anterior Ischemic Optic Neuropathy · Ischemic Optic Neuropathy
Primary: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age — 0.01; 0.01; 0.03; 0.12 incidence rate per 1000 person-years
N/A N=19 MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Nerve Injury
Primary: Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery — 33; 83; 5; 75 score on a scale
Phase 4 N=46 Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Endocrine Dysfunction · Trauma · Brain Injury
Primary: Restricted Functional Independence Measure (FIM) — 34; 16; 21; 52 units on a scale — p=0.9540
N/A N=10 Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease
Thyroid Eye Disease
Primary: Change in IOP Before and After Orbital Decompression Surgery — 18 mVEq (Sensismed Triggerfish output unit)
Phase 2 N=18 Hyperbaric Treatment of Traumatic Brain Injury (TBI)
Traumatic Brain Injury
Primary: Number of Participants With Improved Cerebral Perfusion — 8 Participants
Phase 1 N=19 CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Ocular Hypertension · Open Angle Glaucoma
Primary: Ocular Treatment Emergent Adverse Events — 9; 7; 9; 1 Number of Treatment-Emergent Events
Phase 4 N=20 Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism
Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score
Phase 2 N=50 Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Brain Injury, Chronic
Primary: Computer Cognitive Test Scores - ImPACT Verbal Memory — 70.48; 74.21; 78.12; 75.36 units on a scale
Phase 2 N=71 Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Optic Neuritis
Primary: Retinal Ganglion Cell Inner Plexiform Layer Thickness — 36.56; 34.65; 31; 29.42 micron
N/A N=209 Study of OMNI System in OAG (GEMINI)
Open Angle Glaucoma
Primary: Change in Mean Unmedicated Diurnal IOP — 7.98 mm Hg
N/A N=205 Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)
Tinnitus
Primary: Tinnitus Functional Index — 69.9; 68.2; 47.8; 66.8 units on a scale — p=<.0001
N/A N=97 Electric Stimulation of the Eye to Improve Vision After Trauma
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) · Trauma · Multiple Sclerosis (MS)
Primary: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity — -0.23; -0.14; -0.08; -0.06 logMAR
Phase 4 N=15 Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Growth Hormone Deficiency · Traumatic Brain Injury
Primary: Maximum Oxygen Uptake at Baseline. — 29.0 mL/kg/min
Phase 3 N=200 Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Anemia · Traumatic Brain Injury
Primary: Glasgow Outcome Scale — 17; 17; 34; 37 participants — p=.01
Phase 3 N=13 Inhaled Nitric Oxide in Brain Injury
Traumatic Brain Injury
Primary: PaO2 — 115; 95 mmHg — p=<0.05
N/A N=28 An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
Glaucoma, Open-Angle
Primary: Change in Intraocular Pressure (IOP) — 38.2; 30.1 percent change
N/A N=63 Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Raised Ocular Pressure
Primary: Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position — 9.26; 13.79 mm Hg