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| Name | Class |
|---|---|
| Hospital Evangélico de Belo Horizonte | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing cataract surgery associated with GATT by 360º | Experimental |
| |
| Patients undergoing cataract surgery associated with GATT by 180º | Experimental |
| |
| Patients undergoing only cataract surgery | Other | Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 360º goniotomy assisted transluminal trabeculotomy | Procedure | Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in intraocular pressure (IOP) after 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. | From glaucoma medications washout to 2 years after the surgery |
| Change in the number of glaucoma medications after 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. | From glaucoma medications washout to 2 years after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic factors of the surgeries. | Evaluate the association of IOP variation with axial eye length (AXL) in the groups. | From glaucoma medications washout to 2 years after the surgery |
| Prognostic factors of the surgeries. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have any of the following situations:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel F Moura, MD | Contact | +5531991055860 | dfmoftalmo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais | Recruiting | Belo Horizonte | Minas Gerais | 30150270 | Brazil |
all IPD collected throughout the trial
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The researcher who measures IOP
| Phacoemulsification | Procedure | Cataract Surgery |
|
| 180º gonioscopy assisted transluminal trabeculotomy | Procedure | Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork. |
|
|
Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.
| From glaucoma medications washout to 2 years after the surgery |
| Prognostic factors of the surgeries. | Evaluate the association of IOP variation with age in the groups | From glaucoma medications washout to 2 years after the surgery |
| Survival Analysis | Evaluate and compare the need for new glaucoma surgeries between the groups. | From glaucoma medications washout to 2 years after the surgery |
| Secundary changes in the eye after the surgeries | Evaluate the visual acuity after the surgeries and compare between them. | From glaucoma medications washout to 2 years after the surgery |
| Secundary changes in the eye after the surgeries | Evaluate and compare the adverse events after the surgeries. | From glaucoma medications washout to 2 years after the surgery |
| Secundary changes in the eye after the surgeries | Evaluate the decrease in corneal endothelial cell count between the groups. | From glaucoma medications washout to 2 years after the surgery |
| Prognostic factors, and secundary changes in the eye after the surgeries | Evaluate and compare the change in quality of life in and between the groups. | From glaucoma medications washout to 2 years after the surgery |
| Secundary changes in the eye after the surgeries | Evaluate the induction of astigmatism between the groups | From glaucoma medications washout to 2 years after the surgery |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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