Study: NCT02448875

Adverse event: Eye disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypotony of eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Intraocular pressure fluctuation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 60 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 60 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 60 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 60 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 12 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 21 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 21 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 21 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 61 at risk

Adverse event: Narrow anterior chamber angle
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hyphaema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 61 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 61 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 61 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 18 affected / 61 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk