Study: NCT01881425

Adverse event: Increased IOP Requiring Treatment
Serious: yes
Organ System: Eye disorders
Frequency: 7 affected / 395 at risk

Adverse event: Retinal Complication (Dialysis, Flap Tears, Detachment, Decompression or Proliferative Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Aqueous Humor Misdirection (malignant glaucoma)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Choroidal Effusion / Detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Hypotony (IOP < 6mmHg at any Time)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Glaucoma Progression with Vision Loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 395 at risk

Adverse event: Confirmed Worsening in the Visual Field
Serious: yes
Organ System: Eye disorders
Notes: Confirmed Worsening in the Visual Field Mean Deviation (MD) of ≥ 2.5 DB compared to MD used to determine Subject Eligibility (confirmed on at least 2 out of 3 Visual Field Tests performed after 3 Months Post Procedure)
Frequency: 1 affected / 395 at risk

Adverse event: Increased IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Frequency: 215 affected / 395 at risk

Adverse event: Hypotony (IOP < 6mmHg at any Time)
Serious: no
Organ System: Eye disorders
Frequency: 121 affected / 395 at risk

Adverse event: Subconjunctival Bleeding or Hyphema at any time including Microhyphema
Serious: no
Organ System: Eye disorders
Frequency: 83 affected / 395 at risk

Adverse event: Confirmed Worsening in the Visual Field Mean Deviation
Serious: no
Organ System: Eye disorders
Notes: Confirmed Worsening in the Visual Field Mean Deviation (MD) of ≥ 2.5 DB compared to MD used to determine Subject Eligibility (confirmed on at least 2 out of 3 Visual Field Tests performed after 3 Months Post Procedure)
Frequency: 73 affected / 395 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Frequency: 56 affected / 395 at risk

Adverse event: Loss 2 or More Lines of BCVA
Serious: no
Organ System: Eye disorders
Notes: Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation (excluding Posterior Capsule Opacification, followed by post Nd: YAG Capsulotomy and improvement in BCVA)
Frequency: 55 affected / 395 at risk

Adverse event: Bleb Leak / Bleb Leak Based on Positive Seidel Test
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 395 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 395 at risk

Adverse event: Anterior Chamber Cells and/or Flare
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 395 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 395 at risk

Adverse event: Pain
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 395 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 395 at risk

Adverse event: Flat anterior chamber of eye
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 395 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 395 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 395 at risk

Adverse event: Bleb Related Complications
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 395 at risk

Adverse event: Choroidal Effusion / Detachment
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 395 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 395 at risk

Adverse event: Conjunctival Injection / Conjunctival Hyperemia / Conjunctival Inflammation / Conjunctival Scarring
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 395 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 395 at risk

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 395 at risk

Adverse event: Retinal Complication (Dialysis, Flap Tears, Detachment, Decompression or Proliferative Retinopathy)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 131 at risk

Adverse event: Subconjunctival Bleeding or Hyphema at any time (including Microhyphema)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 131 at risk

Adverse event: Increased IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Frequency: 73 affected / 131 at risk

Adverse event: Hypotony (IOP < 6mmHg at any Time)
Serious: no
Organ System: Eye disorders
Frequency: 67 affected / 131 at risk

Adverse event: Subconjunctival Bleeding or Hyphema at any time including Microhyphema
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 131 at risk

Adverse event: Confirmed Worsening in the Visual Field Mean Deviation
Serious: no
Organ System: Eye disorders
Notes: Confirmed Worsening in the Visual Field Mean Deviation (MD) of ≥ 2.5 DB compared to MD used to determine Subject Eligibility (confirmed on at least 2 out of 3 Visual Field Tests performed after 3 Months Post Procedure)
Frequency: 27 affected / 131 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 131 at risk

Adverse event: Loss 2 or More Lines of BCVA
Serious: no
Organ System: Eye disorders
Notes: Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation (excluding Posterior Capsule Opacification, followed by post Nd: YAG Capsulotomy and improvement in BCVA)
Frequency: 23 affected / 131 at risk

Adverse event: Bleb Leak / Bleb Leak Based on Positive Seidel Test
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 131 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 131 at risk

Adverse event: Anterior Chamber Cells and/or Flare
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 131 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 131 at risk

Adverse event: Pain
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 131 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 131 at risk

Adverse event: Flat anterior chamber of eye
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 131 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 131 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 131 at risk

Adverse event: Bleb Related Complications
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 131 at risk

Adverse event: Choroidal Effusion / Detachment
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 131 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 131 at risk

Adverse event: Conjunctival Injection / Conjunctival Hyperemia / Conjunctival Inflammation / Conjunctival Scarring
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 131 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 131 at risk

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 131 at risk