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Trial record 65 of 1615 for:    glaucoma

Evaluation of the Xen Implant in Glaucoma Surgery (Xen)

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ClinicalTrials.gov Identifier: NCT03733600
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:
Glaucoma is a blinding optic neuropathy that affects 60 million people around the world. Primary open-angle glaucoma is the most common etiology. The therapeutic arsenal now includes medicated hypotonic treatments, lasers and surgery. The most common glaucoma surgery in France is trabeculectomy and non-perforating deep sclerectomy. These are two filtering surgeries whose principle is to lower the intraocular pressure by creating a way of evacuation of the aqueous humor from the anterior chamber of the eye to the space sub conjunctival creating a bubble of filtration. The short-term complications with these techniques are early hypotonia and its attendant complications (choroidal detachment, maculopathy of hypotonia, haemorrhage...). In the medium term, blood pressure with deep anterior chamber, testify to a scleral flap too tight which may require suture lysis. Finally, the problems of excessive conjunctivo-tenon healing affect 25 to 30% of operated and are responsible for the majority of late blood pressure. In the longer term, the most common complication is cataracts. It can be complicated by a very serious endophthalmitis. A new minimally invasive therapeutic option has been developed that limits per and postoperative complications. In contrast to traditional techniques that have an ab externo approach, the ab interno approach of the proposed new technique involves the implantation of a collagen tube 6 mm in length and 45 μm of light called Xen® through the anterior chamber. This surgery can be performed alone or at the same time as a cataract surgery. The geometry of the Xen® implant has been studied to prevent major hypotonia. This new technique would also avoid the complications associated with conjunctival dissection, while being faster. A Xen® implant is nowadays indicated for simple surgery or combined with cataract surgery for open-angle, early-to-moderate, cataract and non-cataract glaucoma, progressive and unbalanced under local hypotonism therapy. Since June 2017, the Xen® technique is part of the routine at GhPSJ.

Condition or disease
Glaucoma

Detailed Description:
The objective of this study is to evaluate the efficacy of surgery with Xen® implantation on intra-ocular pression drop in patients with primary or secondary open-angle glaucoma, beginner to moderate. The study will be proposed to all eligible patients operated between June 2017 and June 2018. After patient's non opposition, clinical data will be collected from patient's medical record.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Glaucoma
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Evaluation of post-operative complications [ Time Frame: year 1 ]
    Post-operative complications will be collected.

  6. Evaluation of reintervention rate [ Time Frame: year 1 ]
    Reintervention number will be collected.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient, operated between June 2017 and June 2018, 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.
Criteria

Inclusion Criteria:

  • Patient 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
  • Patients operated between June 2017 and June 2018

Exclusion Criteria:

  • Patient objecting to participate in the study
  • Patient with other associated ophthalmological disease, except simple cataract already operated or operated simultaneously with the Xen® break without per or postoperative complication
  • History of filter surgery, history of vitrectomy
  • Close angle glaucoma
  • Patient under tutorship or curatorship

Information from the National Library of Medicine

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


Contacts
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Contact: Yves LACHKAR, MD 0144123795 ylachkar@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Helene BEAUSSIER, PhD, PharmD    144127038    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Yves P LACHKAR, MD Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03733600     History of Changes
Other Study ID Numbers: XEN
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases