Trial Outcomes & Findings for 5 Years Long Term Results After Standalone CyPass-Implantation (NCT NCT03114059)

Last Updated: 2022-07-14

Results Overview

The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.

Recruitment status

COMPLETED

Target enrollment

230 participants

Primary outcome timeframe

up to 7 years

Results posted on

2022-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Standalone CyPass Implantation patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Overall Study STARTED	230
Overall Study COMPLETED	230
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standalone CyPass Implantation n=230 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Age, Categorical <=18 years	1 Participants n=230 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=230 Participants
Age, Categorical >=65 years	165 Participants n=230 Participants
Age, Continuous	69 years STANDARD_DEVIATION 12.095 • n=230 Participants
Sex: Female, Male Female	119 Participants n=230 Participants
Sex: Female, Male Male	111 Participants n=230 Participants
Region of Enrollment Germany	230 participants n=230 Participants

PRIMARY outcome

Timeframe: up to 7 years

Population: only 75 study patients were able to visit the clinic and to undergone the 5 year examination, therefore we only could analyse the data of theses75 patients. The number of 230 Patients discribes all patients that fullfil the inclusion criteria.

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=75 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg Target pressure achieved - without medication	8 Participants
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg Target pressure achieved - with medication	45 Participants
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg Target pressure not achieved	22 Participants

PRIMARY outcome

Timeframe: up to 7 years

The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg) The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=75 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) preoperative	21.127 mmHg Standard Deviation 7.831
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) postoperative	16.553 mmHg Standard Deviation 6.633
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) change	-4.697 mmHg Standard Deviation 8.212

PRIMARY outcome

Timeframe: up to 7 years

The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent. The postoperative number of medications after 5 years has to be compared with the preoperative number

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=75 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Additional Medication preoperative	1.813 numbers of active substances Standard Deviation 1.182
Number of Additional Medication postoperative	2.014 numbers of active substances Standard Deviation 1.053
Number of Additional Medication change	0.173 numbers of active substances Standard Deviation 1.201

PRIMARY outcome

Timeframe: up to 7 years

To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=230 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Secondary Glaucoma Procedures	83 Participants

SECONDARY outcome

Timeframe: up to 7 years

Population: for 7 eyes this examination was not done due to low compliance

The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure. With papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings.

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=68 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Stability of Optic Nerve stable	52 Participants
Number of Participants With Stability of Optic Nerve not stable	16 Participants

SECONDARY outcome

Timeframe: up to 7 years

The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=75 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness stable	40 Participants
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness worsening	35 Participants

SECONDARY outcome

Timeframe: up to 7 years

Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end

The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=73 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Stability of Visual Field improvement	11 Participants
Number of Participants With Stability of Visual Field stable	49 Participants
Number of Participants With Stability of Visual Field progression	13 Participants

SECONDARY outcome

Timeframe: up to 7 years

Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=68 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Stability of Stent Position Stent is stable	43 Participants
Number of Participants With Stability of Stent Position Stent moves deeper	12 Participants
Number of Participants With Stability of Stent Position Stent emerges	13 Participants

SECONDARY outcome

Timeframe: up to 7 years

Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=74 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Stability of Stent Tissue Interaction stable	24 Participants
Number of Participants With Stability of Stent Tissue Interaction slight adhesions	32 Participants
Number of Participants With Stability of Stent Tissue Interaction severe adhesions	18 Participants

SECONDARY outcome

Timeframe: up to 7 years

The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=230 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Intra-and Postoperative Complications resistance during implantation	1 Participants
Number of Participants With Intra-and Postoperative Complications heavy bleeding (intraoperative)	6 Participants
Number of Participants With Intra-and Postoperative Complications bad stent positioning	5 Participants
Number of Participants With Intra-and Postoperative Complications increase in pressure: early postoperative	5 Participants
Number of Participants With Intra-and Postoperative Complications increase in pressure	25 Participants
Number of Participants With Intra-and Postoperative Complications increase in pressure: glaucomatous attack	17 Participants
Number of Participants With Intra-and Postoperative Complications hyphema	4 Participants
Number of Participants With Intra-and Postoperative Complications hypotonia	3 Participants
Number of Participants With Intra-and Postoperative Complications early contact to the endothelium	2 Participants
Number of Participants With Intra-and Postoperative Complications age-related macula degeneration	4 Participants
Number of Participants With Intra-and Postoperative Complications gliosis	2 Participants
Number of Participants With Intra-and Postoperative Complications macula edema	1 Participants
Number of Participants With Intra-and Postoperative Complications keratitis	1 Participants
Number of Participants With Intra-and Postoperative Complications dry eyes symptoms	5 Participants
Number of Participants With Intra-and Postoperative Complications fibrin	2 Participants
Number of Participants With Intra-and Postoperative Complications stroke	1 Participants
Number of Participants With Intra-and Postoperative Complications uveitis	1 Participants
Number of Participants With Intra-and Postoperative Complications cataract progression	15 Participants
Number of Participants With Intra-and Postoperative Complications secondary cataract	5 Participants
Number of Participants With Intra-and Postoperative Complications lid tumor	1 Participants
Number of Participants With Intra-and Postoperative Complications pain during operation	3 Participants
Number of Participants With Intra-and Postoperative Complications recurrent neuritis	1 Participants
Number of Participants With Intra-and Postoperative Complications retroiridal cyst	1 Participants
Number of Participants With Intra-and Postoperative Complications total number of complications	111 Participants
Number of Participants With Intra-and Postoperative Complications total number of affected eyes	105 Participants

SECONDARY outcome

Timeframe: up to 7 years

Population: for 12 eyes this examination was not done due to low compliance

The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent

Outcome measures

Outcome measures
Measure	Standalone CyPass Implantation n=63 Participants patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Number of Participants With Suprachoroidal Bleb none	44 Participants
Number of Participants With Suprachoroidal Bleb small	17 Participants
Number of Participants With Suprachoroidal Bleb big	2 Participants

Adverse Events

Standalone CyPass Implantation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standalone CyPass Implantation n=75 participants at risk patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago Glaucoma diagnostics: Heidelberg, Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological determination
Eye disorders Allergic reaction	1.3% 1/75 • Number of events 1 • 1 year

Additional Information

Ahmed Medra

Dietrich-Bonhoeffer-Klinikum

Phone: +49 395 775 13483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place