Assessment of Effectiveness Ex-Press Surgery Modification

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800589
• Other study ID #: 15/WIM/2010
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Secondary
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

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