Study: NCT04333433

Adverse event: Choroidal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 217 at risk

Adverse event: Erosion of the Device through the Conjunctiva
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 217 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 217 at risk

Adverse event: Bullous keratopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 217 at risk

Adverse event: Endothelial Cell Loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 217 at risk

Adverse event: Worsening in the Visual Field Mean Deviation
Serious: no
Organ System: Eye disorders
Notes: Confirmed Worsening in the Visual Field Mean Deviation (MD) ≥2.5dB compared to MD
Frequency: 54 affected / 217 at risk

Adverse event: Increased IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Frequency: 57 affected / 217 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 217 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)
Frequency: 20 affected / 217 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 217 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 217 at risk

Adverse event: Bleb Related Complications
Serious: no
Organ System: Eye disorders
Notes: Bleb Related Complications e.g. cystic bleb, flat bleb
Frequency: 11 affected / 217 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 217 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Notes: Hypotony (IOP \<6mmHg at any Time)
Frequency: 6 affected / 217 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 217 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 217 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 217 at risk

Adverse event: Meibomian Gland Disease
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 217 at risk

Adverse event: Worsening in the Visual Field Mean Deviation
Serious: no
Organ System: Eye disorders
Notes: Confirmed Worsening in the Visual Field Mean Deviation (MD) ≥2.5dB compared to MD
Frequency: 11 affected / 62 at risk

Adverse event: Increased IOP Requiring Treatment
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 62 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 62 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)
Frequency: 4 affected / 62 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 62 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 62 at risk

Adverse event: Bleb Related Complications
Serious: no
Organ System: Eye disorders
Notes: Bleb Related Complications e.g. cystic bleb, flat bleb
Frequency: 3 affected / 62 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 62 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Notes: Hypotony (IOP \<6mmHg at any Time)
Frequency: 8 affected / 62 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 62 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 62 at risk

Adverse event: Meibomian Gland Disease
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 62 at risk