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Clinical Investigation of the eyeWatch Glaucoma Drainage Device

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210571
Recruitment Status : Unknown
Verified July 2017 by Rheon Medical SA.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Rheon Medical SA

Brief Summary:
This study aims to test a new medical device, called the eyeWatch, used in filtering surgery for the treatment of glaucoma. This medical device has the following property: it allows better control of intraocular pressure in the initial postoperative phase by adjusting aqueous flow going through the device. The target criteria for the study are defined as: keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs; evaluating the number and type of postoperative complications. So far, this device has been already tested on 20 patients in Switzerland.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Device: eyeWatch system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the eyeWatch Glaucoma Drainage Device
Estimated Study Start Date : September 4, 2017
Estimated Primary Completion Date : March 4, 2018
Estimated Study Completion Date : March 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Device: eyeWatch system
    The eyeWatch device is composed of an AGDD, a control unit and a draining plate
    Other Name: Adjustable glaucoma drainage device (AGDD)


Primary Outcome Measures :
  1. Number and type of serious adverse device events [ Time Frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline ]

    Demonstration of safety. The number and type of serious adverse device event per patient will be measured.

    Results of biomicroscopy, gonioscopy, pachymetry visual field and endothelial count will be compared to baseline.


  2. Effectiveness in reducing the intraocular pressure [ Time Frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline ]
    Demonstration of the performance. The intraocular pressure (IOP in mmHg) will be measured at different time points to show the effective reduction compared to baseline. IOP reduced by ≥ 20% or IOP < 21 mmHg, and no IOP < 5 mmHg on two consecutive visits after 1 month (included)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Patient shall suffer from primary open angle glaucoma, pseudo-exfoliative glaucoma, or refractory POAG or PEXG after previous failed filtering surgery, in the study eye. Diagnosis is based on glaucomatous optic neuropathy, Shaffer angle greater than 2 as seen on gonioscopy, and visual field defect attributed to glaucoma.
  • Eye to be treated shall be phakic or pseudophakic with no other active ocular disease or disorder except for incipiens cataract. Prior ophthalmic surgery in the study eye shall have been performed more than 3 months before enrollment in this study.
  • Patient condition is indicated for primary and secondary filtration surgery.
  • Presence of elevated intraocular pressure defined as an intraocular corrected pressure (IOP) > 20 mmHg in the study eye, under maximally tolerated medications. The IOP level shall be obtained on 2 consecutive measurements (not taken on the same day) prior to surgery.
  • Optic neuropathy is exclusively attributed to glaucoma.
  • Patient agreed to sign the written inform consent prior to entering into the investigation.
  • Patient is able and willing to complete post-operative follow-up requirements.

Exclusion Criteria:

  • Diagnosis of neovascular glaucoma, congenital glaucoma.
  • History of previous intraocular surgery in the study eye referring to but not limited to extraocular muscles (strabismus), corneal transplant, retinal surgery.
  • Proliferative or severe non-proliferative retinopathy in either eye.
  • Congenital anomaly of the anterior chamber angle in the study eye.
  • Optic neuropathy other than glaucoma in the study eye.
  • Patient with retinal vein occlusion in the study eye.
  • Patient with retinal artery occlusion in the study eye.
  • Patient with corneal opacifications, endotheliopathy, or irregularities that may interfere with the optic nerve evaluation or the IOP measurements in the study eye.
  • Patient with a history of severe eye trauma in the study eye.
  • Patient with ocular malformations such as microphthalmia in the study eye.
  • Patient with concurrent inflammatory/infective eye disorder in the study eye.
  • Patient with severe systemic disease or disabling conditions such as chronic renal failure, post organ transplants.
  • Patient participating in another clinical trial or having participated in another clinical trial less than 3 months prior to entering into the investigation.
  • Patient is pregnant, breast-feeding or unable to make the decision to participate in a clinical investigation (e.g. mentally ill person, mentally handicapped person)

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): NCT03210571


Contacts
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Contact: Adan Villamarin, Phd +41216938335 adan.villamarin@epfl.ch

Sponsors and Collaborators
Rheon Medical SA
Publications:
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Responsible Party: Rheon Medical SA
ClinicalTrials.gov Identifier: NCT03210571    
Other Study ID Numbers: 3007
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan

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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
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases