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

March 5, 2025 updated by: DANIEL FULGENCIO DE MOURA, Faculdade de Ciências Médicas de Minas Gerais

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150270
        • Recruiting
        • Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients undergoing cataract surgery associated with GATT by 360º
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
Experimental: Patients undergoing cataract surgery associated with GATT by 180º
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.
Other Names:
  • 180º GATT
  • Hemi - GATT
Other: Patients undergoing only cataract surgery
Control Group
Procedure: Phacoemulsification
Cataract Surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
From glaucoma medications washout to 2 years after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Evaluate the association of IOP variation with preoperative anterior chamber amplitude (ACD) in the groups.
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
Evaluate the association of IOP variation with age in the groups
From glaucoma medications washout to 2 years after the surgery
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.
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
Evaluate the visual acuity after the surgeries and compare between them.
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
Evaluate and compare the adverse events after the surgeries.
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
Evaluate the decrease in corneal endothelial cell count between the groups.
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
Evaluate and compare the change in quality of life in and between the groups.
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
Evaluate the induction of astigmatism between the groups
From glaucoma medications washout to 2 years after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculdade de Ciências Médicas de Minas Gerais

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Evangélico de Belo Horizonte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 76604823.8.0000.5134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD collected throughout the trial

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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