Evaluation of the Xen Implant in Glaucoma Surgery (Xen)
|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: NCT03733600|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 8, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Evaluation of the Xen Implant in Glaucoma Surgery|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
All patients followed for either early or moderate forms of primary or secondary open-angle glaucoma who had undergone surgery for Xen alone or in combination with cataract surgery for phacoemulisation of the lens.
- Evaluation of the efficiency of surgery with Xen [ Time Frame: year 1 ]The success of surgery will be evaluate with the intra-ocular pressure's measurement. Complete success corresponds to Intra-ocular pressure between 5 and 18 mmHg, with a relative decrease of more than 20% compared to the initial intra-ocular pressure, without having resorted to hypotonic treatments. Partial success corresponds to intra-ocular pressure between 5 and 18 mmHg but with an intra-ocular pressure reduction of less than 20% or with maintenance of a hypotonizing treatment. Therapeutic failure is defined as an intra-ocular pressure strictly greater than 18 mmHg or less than 5 mmHg.
- Evaluation of visual activity [ Time Frame: year 1 ]Visual acuity will be measure and compare to the preoperative visit to evaluate the efficiency of Xen.
- Evaluation of visual fieldwill [ Time Frame: year 1 ]The visual fieldwill be measure and compare to the preoperative visit in order to evaluate the Xen's efficiency.
- Measurement of Optic nerve excavation [ Time Frame: year 1 ]Optic nerve excavation will be measure and compare to the preoperative visit in order to evaluate of the efficiency of Xen.
- Evaluation of the efficiency of Xen [ Time Frame: year 1 ]Number of hypotonizing drugs will be collecte and compare to the preoperative visit to evaluate yhe efficiency of Xen.
- Evaluation of post-operative complications [ Time Frame: year 1 ]Post-operative complications will be collected.
- Evaluation of reintervention rate [ Time Frame: year 1 ]Reintervention number will be collected.
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): NCT03733600
|Contact: Yves LACHKAR, MDemail@example.com|
|Groupe Hospitalier Paris Saint-Joseph||Recruiting|
|Paris, France, 75014|
|Contact: Helene BEAUSSIER, PhD, PharmD 144127038 firstname.lastname@example.org|
|Principal Investigator:||Yves P LACHKAR, MD||Groupe Hospitalier Paris Saint Joseph|