Glaucoma, Open-Angle, Glaucoma, Primary Open Angle, Glaucoma Secondary
Conditions
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.
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.
Interventions
PROCEDUREphacoemulsification 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.
PROCEDUREdeep 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.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized control study with 24-month follow-up.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | baseline, and 24th month after surgery | the change in level of intraocular pressure |
| CDVA | baseline, and 24th month after surgery | the change in corrected distance visual acuity |
| number of drugs | baseline, and 24th month after surgery | the change in number of antiglaucoma medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of complications | in a day of surgery | rate of complications |
Outcome results
None listed