Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
To assess the impact of the type of intervention (NPDS or XEN® placement) on endothelial cell loss 2 years after the intervention |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
2 years |
|
Secondary |
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
1 year postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
2 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
3 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
4 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure |
Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density |
5 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 10% calculated from basal cell density |
2 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 10% calculated from basal cell density |
3 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 10% calculated from basal cell density |
4 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 10% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 10% calculated from basal cell density |
5 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 20% calculated from basal cell density |
2 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 20% calculated from basal cell density |
3 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 20% calculated from basal cell density |
4 years postoperative |
|
Secondary |
Evaluate the impact of the type of intervention on the incidence of cell loss of more than 20% after surgery procedure |
Difference between the two eye groups in terms of percentage cell loss = 20% calculated from basal cell density |
5 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
2 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
3 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
4 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the XEN implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
5 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
1 year postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
2 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
3 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
4 years postoperative |
|
Secondary |
Evaluate the impact of the position in the anterior chamber of the implant on cell loss after surgery procedure |
in the eye group operated with XEN® placement: distribution of cell loss according to the position in the anterior chamber of XEN® determined by OCT photographs of the anterior chamber |
5 years postoperative |
|