Cataract Open Angle Glaucoma
Conditions
Interventions
A randomized clinical trial with two parallel arms comparing two minimally invasive glaucoma surgery techniques combined with phacoemulsification, in patients with open-angle glaucoma, pigmentary glau
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Consecutive patients with primary open-angle glaucoma, treated ocular hypertension, pigmentary glaucoma or pseudoexfoliation glaucoma; presence of a visually significant cataract; minimum age of 40 years at the date of the procedure; ability to complete postoperative follow-up for at least 12 months
Exclusion criteria
Exclusion criteria: Narrow iridocorneal angle (Shaffer I to II) or other visible angle abnormality; clinically significant corneal dystrophy; central corneal thickness below 480 micrometers or above 620 micrometers; prior intraocular surgery, cycloablative procedure or non-selective laser trabeculoplasty (argon laser trabeculoplasty); recent selective laser trabeculoplasty, less than 90 days; history of ocular trauma; advanced primary open-angle glaucoma, defined by visual field mean deviation below -12.0 decibels with corresponding optic nerve damage; angle-closure glaucoma, neovascular glaucoma, secondary glaucomas except pigmentary and pseudoexfoliation, juvenile glaucoma and congenital glaucoma; other ocular disease such as proliferative diabetic retinopathy or exudative age-related macular degeneration; any medical condition that prevents obtaining reliable and valid data; enrollment in another prospective clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the mean change in intraocular pressure from baseline at 12 months, comparing the Phaco-GATT and Phaco-KDB groups. Verified through intraocular pressure measurement by Goldmann applanation, using the two-operator masked method described in the Ocular Hypertension Treatment Study. The mean intraocular pressure reduction in millimeters of mercury in each group and the between-group difference will be analyzed, this being the outcome used for the sample size calculation;To assess the rate of pressure success at 12 months. Verified through intraocular pressure measurement by Goldmann applanation and the count of hypotensive medications. The proportion of eyes achieving success will be observed, defined as an intraocular pressure reduction greater than 20 percent from baseline or attainment of the pre-defined target intraocular pressure, with or without a reduction of at least one hypotensive medication relative to preoperative therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in the number of hypotensive medications at 12 months relative to preoperative therapy, verified through the method of counting the hypotensive active ingredients in use at each visit, from which we will observe the difference in the number of medications between baseline and 12 months in each group;To assess surgical and visual success at 12 months, verified through the method of ophthalmological clinical examination, count of additional glaucoma surgeries, corrected visual acuity measurement on the Snellen chart and specular microscopy, from which we will observe the proportion of eyes with no need for additional surgery and no loss of one corrected Snellen line and the change in endothelial cell density between baseline and 12 months;To assess the occurrence of intraoperative and postoperative complications over 12 months, verified through the method of ophthalmological clinical examination at each follow-up visit, from which we will observe the rates of hyphema, intraocular pressure spike above 30 millimeters of mercury in the first postoperative month, iridodialysis and Descemet membrane rupture ;To assess predictors of surgical success at 12 months, verified through the method of statistical association analysis between success and preoperative and intraoperative variables, from which we will observe the association of success with intraoperative episcleral blanching, the degree of preoperative trabecular meshwork pigmentation and prior selective laser trabeculoplasty | — |
Countries
BR
Contacts
Public ContactGuilherme Guedes
Guilherme Barroso Guedes
Outcome results
None listed