Eye Diseases
Conditions
Interventions
Xen 45 implant
Deep sclerectomy with mitomycin C
Sponsors
University of the Witwatersrand Faculty of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • CMJAH eye clinic adult patients (18 years of age or older) • Bilateral open angle glaucoma (primary open-angle glaucoma (POAG), exfoliation glaucoma (XFG) or pigment dispersion syndrome (PDS)) requiring surgery to both eyes: o GLAUCOMA DIAGNOSIS will be based on the appearance of the optic nerve head, open angles on gonioscopy, optical coherence tomography (OCT) structural assessments and humphrey visual field changes o REQUIREMENTS FOR SURGERY: ? IOP greater than 18mmHg despite maximal tolerated medical therapy ? Progression of optic nerve cupping, thinning of the retinal nerve fibre layer or progression of visual field defects despite maximal tolerated medical therapy
Exclusion criteria
Exclusion criteria: • Post-traumatic and angle-recession glaucoma • Neovascular glaucoma • Uveitic glaucoma • Occludable angles on gonioscopy • Previous intra-ocular surgery other than uncomplicated cataract surgery • Prior conjunctival surgery or pathology • Active inflammation (blepharitis, conjunctivitis, keratitis, uveitis) • Impaired episcleral venous pressure (for example Sturge-Weber syndrome, nanophthalmos or thyroid eye diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Cost •Surgical time •Disposables and devices •Post-operative medication •Follow-up visits •Additional procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure ;Success • A COMPLETE SUCCESS will be defined as an IOP of less than or equal to 18mmHg and an IOP reduction greater than or equal to 30% without glaucoma medication or compared with a pre-operative level. In addition there must be no progression of optic nerve cupping or visual field changes • A QUALIFIED SUCCESS will be defined as an IOP less than or equal to 18mmHg with glaucoma medication or an IOP reduction of less than 30% compared with a pre-operative level in the absence of glaucoma progression • A QUALIFIED FAILURE will be defined as an IOP greater than 18mmHg despite glaucoma medication but without detectable optic nerve or visual field deterioration • A COMPLETE FAILURE will be an eye requiring a second glaucoma drainage surgery or losing visual function;Number of glaucoma medications used | — |
Countries
South Africa
Contacts
Public ContactSusan Williams
Lecturer
Outcome results
None listed