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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800589
Other study ID # 15/WIM/2010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2010
Est. completion date December 1, 2017

Study information

Verified date January 2019
Source Military Institute of Medicine, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date December 1, 2017
Est. primary completion date December 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Military Institute of Medicine, Poland

References & Publications (1)

Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IOP the change in level of intraocular pressure baseline, and 24th month after surgery
Primary CDVA the change in corrected distance visual acuity baseline, and 24th month after surgery
Primary number of drugs the change in number of antiglaucoma medications baseline, and 24th month after surgery
Secondary number of complications rate of complications in a day of surgery
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