Comparing treatments for open-angle glaucoma and cataract

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with primary open-angle glaucoma (OAG) and cataract. Participants aged 40 and older will be randomly assigned to different treatment groups and monitored over two years for changes in intraocular pressure (IOP), medication usage, and visual acuity. The study aims to assess the impact of these interventions on patient quality of life and potential adverse effects. The trial includes a comprehensive analysis of various factors influencing treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion 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 with thinning of the neural rhyme, asymmetry of the cup/disc ratio greater than 0.2, localized loss ("notch") or defect in the retinal nerve fiber layer ("Hoyt")).
* 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.

Exclusion Criteria:

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.

Where it's running

• Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
  Belo Horizonte, Minas Gerais, Brazil Recruiting

Study contacts

• Study coordinator: Daniel F Moura, MD
• Email: dfmoftalmo@gmail.com
• Phone: +5531991055860

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cataract surgery with iStent inject versus Kahook Dual Blade goniotomy for open-angle glaucoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.