NCT06865235Recruiting
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 15 Feb 2025
- Start date
- 7 May 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- Faculdade de Ciências Médicas de Minas Gerais
- Diseases
- Glaucoma
- NCT number
- NCT06865235
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 7 May 2024 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative period;
- 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.
Lab values
- Endothelial count less than 1500 cc;
Other
- 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;
- Pachymetry less than 480 or greater than 600 microns;
- Those who present some important per-operative complication during the study.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.