Trial Outcomes & Findings for Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation (NCT NCT04547036)
NCT ID: NCT04547036
Last Updated: 2021-07-13
Results Overview
The primary endpoint is the change of central endothelial cell density compared to preoperative data.
Recruitment status
COMPLETED
Target enrollment
129 participants
Primary outcome timeframe
baseline compared to 1-5 years postoperative
Results posted on
2021-07-13
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
XEN45 Implantation With and Without Combined Cataract Surgery
Patients with history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination
|
|---|---|
|
Overall Study
STARTED
|
129 155
|
|
Overall Study
COMPLETED
|
129 155
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
Baseline characteristics by cohort
| Measure |
XEN45 Implantation With and Without Combined Cataract Surgery
n=155 Eyes
Eyes with a history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination.
|
|---|---|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 10.3 • n=14 Eyes
|
|
Sex: Female, Male
Female
|
66 Eyes
n=14 Eyes
|
|
Sex: Female, Male
Male
|
89 Eyes
n=14 Eyes
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Eyes
n=14 Eyes
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Eyes
n=14 Eyes
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
Asian
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
White
|
155 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
|
Region of Enrollment
Austria
|
155 Eyes
n=14 Eyes
|
PRIMARY outcome
Timeframe: baseline compared to 1-5 years postoperativeThe primary endpoint is the change of central endothelial cell density compared to preoperative data.
Outcome measures
| Measure |
Endothelial Cell Count Measurment
n=155 eyes
XEN45: Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.
|
|---|---|
|
Endothelial Cell Count Change
1 year
|
2 % change compared to baseline
Interval -1.0 to 5.0
|
|
Endothelial Cell Count Change
2 years
|
-1 % change compared to baseline
Interval -3.0 to 0.0
|
|
Endothelial Cell Count Change
3 years
|
0 % change compared to baseline
Interval -3.0 to 2.0
|
|
Endothelial Cell Count Change
4 years
|
-4 % change compared to baseline
Interval -7.0 to 1.0
|
|
Endothelial Cell Count Change
5 years
|
-1 % change compared to baseline
Interval -7.0 to 4.0
|
Adverse Events
XEN45 Implantation With and Without Combined Cataract Surgery
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
XEN45 Implantation With and Without Combined Cataract Surgery
n=129 participants at risk
Patients with history past XEN45 implantation with and without combined cataract surgery and preoperatively recorded baseline central endothelial cell counts were included for the postoperative examination
|
|---|---|
|
Eye disorders
Adult Macular degeneration
|
15.5%
20/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Conjunctival hyperemia
|
3.9%
5/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Retinal haemorrhage
|
2.3%
3/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
conreal guttae
|
1.6%
2/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Conjuncitval emema
|
1.6%
2/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Cystoid macular edema
|
1.6%
2/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Conjuncitval hemorhage
|
0.78%
1/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
|
Eye disorders
Epiretinal membrane
|
1.6%
2/129 • 3.7 (range 1.6-6.7) years
The investigators classified the adverse events based on the following definitions according to ISO 14155 (2011). Adverse Event (AE) Adverse Device Effect (ADE) Device deficiency Serious Adverse Event (SAE) Serious Adverse Device Effect (SADE)
|
Additional Information
PD Dr. Markus Lenzhofer PhD FEBO
Dept. Ophthalmology at Paracelsus Medical University Salzburg
Phone: +43 57255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place