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Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery

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: NCT03201354
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
Gregorio Marañón Hospital
Clinica Universidad de Navarra, Universidad de Navarra
Hospital Vall d'Hebron
Hospital Universitario Ramon y Cajal
Hospital San Eloy
Hospital del Mar
Information provided by (Responsible Party):
Institut Catala de Retina

Brief Summary:

The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy.

In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.


Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Procedure: Filtration surgery with Ex-PRESS Procedure: Non penetrating deep sclerectomy Procedure: Cataract extraction Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery: Prospective, Multi-center, Comparative Study
Study Start Date : February 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Active Comparator: Filtration surgery with Express
Filtration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation)
Procedure: Filtration surgery with Ex-PRESS
Filtration surgery with Ex-PRESS

Procedure: Cataract extraction
Cataract surgery and IOL implantation

Active Comparator: Non penetrating surgery
- Filtration surgery with Non penetrating deep sclerectomy + cataract extraction (Cataract surgery and IOL implantation)
Procedure: Non penetrating deep sclerectomy
Non penetrating deep sclerectomy

Procedure: Cataract extraction
Cataract surgery and IOL implantation




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Up to 12 months ]
    mmHg


Secondary Outcome Measures :
  1. Success rate at IOP <18 [ Time Frame: Up to 12 months ]
    percentage of patients with < of 18 mmHg in intraocular pressure

  2. Number of participants with adverse events assesed by questionare in case report file. [ Time Frame: Up to 12 months ]

    Bullet list of complications to check for at each study visit from the date of randomization upt to 12 months

    List of complications in Case report file:

    Avascular bleb Bleb fibrosis Choroidal effusion Corectopia Corneal edema Corneal erosion Cystoid macular edema Descemet folds Epiretinal membrane Fibrin IOL Foreign body sensation Hematic tyndall Hypotony > 1 month Hypotony Maculopathy Iris incarceration Iris synechiae Lamellar macular hole Posterior capsule opacity Postoperative shunt closure Postoperative uveitis Seidel (early) Shallow anterior chamber Subconjunctival hemorrhage Tenon Cist Transient hypotony VA declined > 2 Snellen lines Vitreous in anterior chamber


  3. Number of hypotensive medications needed [ Time Frame: Up to 12 months ]
    Number of drugs prescribed by investigator to keep IOP under target from the date of randomization up to 12 months



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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:

  1. Diagnosis of open-angle glaucoma. Points a, b and c will be required:

    1. Glaucomatous visual field. Defined as the field presenting at least:

      • A group of 3 or more points with p < 5% in the pattern deviation map AND
      • One of them with a p < 1% in the pattern deviation map AND
      • Repeated in at least 2 VF.
    2. Glaucomatous optic nerve. Defined as the optic nerve observed in color photographs presenting:

      • Thinning of the neuroretinal rim that can be demonstrated by an alteration in the ISNT rule.
      • Presence of a notch "or"
      • Presence of papillary splinter hemorrhage "or"
      • Presence of a nerve fiber layer defect "or"
      • Cup to disc (C/D) ratio asymmetry > 0.3 that cannot be explained by asymmetry in the optic disc size "or"
      • C/D ratio > 0.8 that cannot be explained by a large optic disc size
    3. III or IV angle in Shaffer classification
  2. Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)
  3. Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)

Exclusion Criteria:

  1. Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < ‐20 dB)
  2. Previous glaucoma surgery
  3. Previous intraocular ocular surgery

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): NCT03201354


Locations
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Spain
Institut Catala de Retina
Barcelona, Spain, 08017
Sponsors and Collaborators
Institut Catala de Retina
Gregorio Marañón Hospital
Clinica Universidad de Navarra, Universidad de Navarra
Hospital Vall d'Hebron
Hospital Universitario Ramon y Cajal
Hospital San Eloy
Hospital del Mar
Investigators
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Principal Investigator: Alfonso Antón, MD, PhD Institut Catala de Retina
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Responsible Party: Institut Catala de Retina
ClinicalTrials.gov Identifier: NCT03201354    
Other Study ID Numbers: ICR-01 Ex-PRESS
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Keywords provided by Institut Catala de Retina:
Glaucoma
Ocular hypertension
Filtration surgery
Trabeculectomy with Ex-PRESS
Non penetrating deep sclerectomy
Phacoemulsification
Combined surgery
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases