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Completed

NCT Number: NCT03800589

Assessment of Effectiveness Ex-Press Surgery Modification

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification with implantation of the Ex-Press

Procedure

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.

deep sclerectomy, phacoemulsification, ExPress implantation

Procedure

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 outcomes

  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 outcomes

  1. number of complications

    Time frame: in a day of surgery

    rate of complications

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jan 11, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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