Investigation of the iStent Inject® Devices in Open-Angle Glaucoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03624699|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-Angle||Device: Glaukos iStent inject®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Historic control (before vs. after intervention).|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma|
|Actual Study Start Date :||April 25, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Glaukos iStent inject®
Patients suffering from cataract and open-angle glaucoma. Glaukos iStent inject® is implanted during routine cataract surgery. The effect on IOP/glaucoma medications is monitored.
Device: Glaukos iStent inject®
iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma
- Performance Outcome: IOP reduction [ Time Frame: 12 months ]Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
- Quality of life: NEI VFQ-25 score [ Time Frame: 12 months ]Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months.
- Safety Outcome: Adverse events [ Time Frame: 12 months ]Rate of adverse events through the follow-up period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624699
|Contact: Kaweh Mansouri, MD MPH||021 619 37 42 ext +firstname.lastname@example.org|
|Contact: André Mermoud, MD||021 619 37 42 ext +email@example.com|
|Glaucoma Research Centre, Montchoisi Clinic||Recruiting|
|Lausanne, VD, Switzerland, 1006|
|Contact: Kaweh Mansouri, MD MPH 021 619 37 42 ext +41 firstname.lastname@example.org|
|Contact: André Mermoud, MD 021 619 37 42 ext +41 email@example.com|
|Principal Investigator: Kaweh Mansouri, MD MPH|
|Principal Investigator: André Mermoud, MD|
|Principal Investigator: Kevin Gillmann, MBBS MArch|
|Study Director:||Kaweh Mansouri, MD MPH||Glaucoma Research Centre, Montchoisi Clinic, Lausanne|
|Study Director:||André Mermoud, MD||Glaucoma Research Centre, Montchoisi Clinic, Lausanne|