Comparing treatments for 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
This study is testing a new eye surgery for people with both open-angle glaucoma and cataracts to see if it can lower eye pressure and improve their vision and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Faculdade de Ciências Médicas de Minas Gerais Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Trial ID | NCT06865235 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older with mild to moderate primary open-angle glaucoma and cataract requiring surgery.
Not a fit: Patients with severe glaucoma or those who do not require cataract surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with open-angle glaucoma and cataract, potentially reducing the need for medications and enhancing visual outcomes.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Belo Horizonte, Minas Gerais
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.