Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, 30150270, Brazil
Location status: Recruiting
NCT Number: NCT06865235
Prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (IOP) of patients with mild or moderate primary open-angle glaucoma (OAG) and cataract divided into three groups. All study participants should be treated for the pathology with one or more hypotensive medications or, regardless of the number of drugs, when IOP is greater than 20 mmHg and less than 26 mmHg. The two-year follow-up should also compare the reduction in the number of medications used, reoperation rate, adverse effects, visual acuity, endothelial loss, induction of astigmatism, variation in IOP according to axial diameter of the eye, anterior chamber and age, in addition to the existence of change in the quality of life of patients in the postoperative period
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Belo Horizonte, Minas Gerais, 30150270, Brazil
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who have any of the following situations:
Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.
Cataract Surgery
Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.
Other names: 180º GATT, Hemi - GATT
Time frame: From glaucoma medications washout to 2 years after the surgery
To evaluate the change in intraocular pressure (IOP) after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
Time frame: From glaucoma medications washout to 2 years after the surgery
To evaluate the change in the number of glaucoma medications applied after surgery, in patients with mild to moderate GPAA, undergoing phacoemulsification associated with gonioscopy assisted transluminal trabeculotomy by 180º (GATT 180º) or 360º (GATT 360º), and compare the results between the groups mentioned and with similar controls, who operated only on cataracts, in a period of up to two years.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the association of IOP variation with axial eye length (AXL) in the groups.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the association of IOP variation with age in the groups
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate and compare the need for new glaucoma surgeries between the groups.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the visual acuity after the surgeries and compare between them.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate and compare the adverse events after the surgeries.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the decrease in corneal endothelial cell count between the groups.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate and compare the change in quality of life in and between the groups.
Time frame: From glaucoma medications washout to 2 years after the surgery
Evaluate the induction of astigmatism between the groups
Contact information is provided by the study sponsor or research team.
Faculdade de Ciências Médicas de Minas Gerais
Other
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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