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NCT Number: NCT06865235

Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais

Belo Horizonte, Minas Gerais, 30150270, Brazil

Location status: Recruiting

Location contact

Bruno L Trindade, PhD

CONTACT

[email protected]

+553132487450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

360º goniotomy assisted transluminal trabeculotomy

Procedure

Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.

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.

Other names: 180º GATT, Hemi - GATT

Primary outcomes

  1. Change in intraocular pressure (IOP) after surgery.

    Time frame: From glaucoma medications washout to 2 years after the 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.

  2. Change in the number of glaucoma medications after surgery.

    Time frame: From glaucoma medications washout to 2 years after the 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.

Secondary outcomes

  1. Prognostic factors of the surgeries.

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the association of IOP variation with axial eye length (AXL) in the groups.

  2. Prognostic factors of the surgeries.

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.

  3. Prognostic factors of the surgeries.

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the association of IOP variation with age in the groups

  4. Survival Analysis

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate and compare the need for new glaucoma surgeries between the groups.

  5. Secundary changes in the eye after the surgeries

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the visual acuity after the surgeries and compare between them.

  6. Secundary changes in the eye after the surgeries

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate and compare the adverse events after the surgeries.

  7. Secundary changes in the eye after the surgeries

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the decrease in corneal endothelial cell count between the groups.

  8. Prognostic factors, and secundary changes in the eye after the surgeries

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate and compare the change in quality of life in and between the groups.

  9. Secundary changes in the eye after the surgeries

    Time frame: From glaucoma medications washout to 2 years after the surgery

    Evaluate the induction of astigmatism between the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel F Moura, MD

CONTACT

[email protected]

+5531991055860

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas de Minas Gerais

Other

Collaborators

  • Hospital Evangélico de Belo Horizonte

Registry information

Official study title

Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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