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Tests treatment safety and results for Open Angle Glaucoma (OAG)
Official title Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
ClinicalTrials.gov ID: NCT06865235
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Patients aged 40 years or older,
- Previously included in the glaucoma departments of the participating institutions,
- Indication for cataract surgery, diagnosed by clinical examination with visual acuity (VA) equal to or worse than 20/40,
- Primary Open Angle Glaucoma (POAG), determined by the presence of typical visual field (VF) defects and/or by the aspect of the optic nerve observed...
- APIC classification with amplitude greater/equal to 2 and pigmentation less than 4 on gonioscopy.
You likely can't join if
- Patients who have any of the following situations:
- Severe glaucoma, determined according to the Hoddap-Parrish-Anderson criteria;
- Axial diameter greater than 26 mm or less than 21.00 mm;
- Endothelial count less than 1500 cc;
- Pachymetry less than 480 or greater than 600 microns;
- Patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative...
See the full eligibility criteria
- Patients aged 40 years or older,
- Previously included in the glaucoma departments of the participating institutions,
- Indication for cataract surgery, diagnosed by clinical examination with visual acuity (VA) equal to or worse than 20/40,
- Primary Open Angle Glaucoma (POAG), determined by the presence of typical visual field (VF) defects and/or by the aspect of the optic nerve observed at fundoscopy or retinography (increased vertical optical excavation...
- APIC classification with amplitude greater/equal to 2 and pigmentation less than 4 on gonioscopy.
- Intraocular pressure (IOP) less than or equal to 25 mmHg before washout of hypotensive eye drops.
- IOP between 22 and 30 mmHg after washout of hypotensive eye drops or with a history of IOP greater than or equal to 21 mmHg in more than one previous care described in the medical record.
- Patients who have any of the following situations:
- Severe glaucoma, determined according to the Hoddap-Parrish-Anderson criteria;
- Axial diameter greater than 26 mm or less than 21.00 mm;
- Endothelial count less than 1500 cc;
- Pachymetry less than 480 or greater than 600 microns;
- Patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative period;
- Those who present some important per-operative complication during the study.
- With high risk of progression, the so-called rapid progressors, who are patients with high IOPs even with the use of many medications, regardless of the severity of the nerve injury.
The study team makes the final eligibility decision.
Where it's taking place
- Belo Horizonte, Minas Gerais, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belo Horizonte, Minas Gerais, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.