Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 360º goniotomy assisted transluminal trabeculotomy, Phacoemulsification, 180º gonioscopy assisted transluminal trabeculotomy.
- Who it may be relevant to
- Registry conditions: Open Angle Glaucoma (OAG). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial
Overview
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
Interventions
- Procedure 360º goniotomy assisted transluminal trabeculotomy
Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork. - Procedure Phacoemulsification
Cataract Surgery - Procedure 180º gonioscopy assisted transluminal trabeculotomy
Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.
Primary outcome measures
- Change in intraocular pressure (IOP) after surgery. [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Change in the number of glaucoma medications after surgery. [Time frame: From glaucoma medications washout to 2 years after the surgery]
Secondary outcome measures (9)
- Prognostic factors of the surgeries. [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Prognostic factors of the surgeries. [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Prognostic factors of the surgeries. [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Survival Analysis [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Secundary changes in the eye after the surgeries [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Secundary changes in the eye after the surgeries [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Secundary changes in the eye after the surgeries [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Prognostic factors, and secundary changes in the eye after the surgeries [Time frame: From glaucoma medications washout to 2 years after the surgery]
- Secundary changes in the eye after the surgeries [Time frame: From glaucoma medications washout to 2 years after the surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais — Belo Horizonte
Identifiers
NCT: NCT06865235 · 76604823.8.0000.5134