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Assessment of Effectiveness Ex-Press Surgery Modification

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ClinicalTrials.gov Identifier: NCT03800589
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Military Institute of Medicine, Poland

Brief Summary:
The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Glaucoma Secondary Glaucoma, Primary Open Angle Procedure: phacoemulsification with implantation of the Ex-Press Procedure: deep sclerectomy, phacoemulsification, ExPress implantation Not Applicable

Detailed Description:
Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized control study with 24-month follow-up.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
Actual Study Start Date : December 1, 2010
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: phaco and Ex-Press
patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press
Procedure: phacoemulsification with implantation of the Ex-Press
The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.

Active Comparator: deep sclerectomy, phaco and Ex-press
patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation
Procedure: deep sclerectomy, phacoemulsification, ExPress implantation
The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.




Primary Outcome Measures :
  1. IOP [ Time Frame: baseline, and 24th month after surgery ]
    the change in level of intraocular pressure

  2. CDVA [ Time Frame: baseline, and 24th month after surgery ]
    the change in corrected distance visual acuity

  3. number of drugs [ Time Frame: baseline, and 24th month after surgery ]
    the change in number of antiglaucoma medications


Secondary Outcome Measures :
  1. number of complications [ Time Frame: in a day of surgery ]
    rate of complications



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
  • patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
  • documented progression of loss of field of vision,
  • significant daily IOP fluctuations,
  • no cooperation from patient with regard to application of anti-glaucoma treatment,
  • allergy to topical medication
  • written consent to involvement and participation in the study for a period of at least 24 months

Exclusion Criteria:

  • no consent to participation in the study
  • prior surgical and laser procedures in the area of the eye
  • narrow- or closed-angle glaucoma
  • post-inflammatory or post-traumatic secondary glaucoma
  • chronic illness of the cornea or optic nerve
  • advanced macular degeneration
  • active inflammatory process
  • pregnancy
  • systemic steroid therapy

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): NCT03800589


Sponsors and Collaborators
Military Institute of Medicine, Poland
Investigators
Principal Investigator: Marek Rękas, Prof Military Institute of Medicine in Warsaw

Publications of Results:
Responsible Party: Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT03800589     History of Changes
Other Study ID Numbers: 15/WIM/2010
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 18 months of study completion
Access Criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement

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

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases