Actively Recruiting
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
Led by Faculdade de Ciências Médicas de Minas Gerais · Updated on 2025-03-07
90
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
F
Faculdade de Ciências Médicas de Minas Gerais
Lead Sponsor
H
Hospital Evangélico de Belo Horizonte
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 years or older
- Previously included in the glaucoma departments of the participating institutions
- Indication for cataract surgery with visual acuity equal to or worse than 20/40
- Diagnosis of primary open-angle glaucoma confirmed by typical visual field defects and/or optic nerve changes
- APIC classification with amplitude greater or equal to 2 and pigmentation less than 4 on gonioscopy
- Intraocular pressure less than or equal to 25 mmHg before washout of hypotensive eye drops
- Intraocular pressure between 22 and 30 mmHg after washout of hypotensive eye drops or history of IOP ≥21 mmHg in multiple prior visits
You will not qualify if you...
- Severe glaucoma determined by Hoddap-Parrish-Anderson criteria
- Axial diameter greater than 26 mm or less than 21.00 mm
- Endothelial cell count less than 1500 cells/mm²
- Corneal thickness (pachymetry) less than 480 or greater than 600 microns
- Recent or planned intraocular surgery or laser procedures before or after the study
- Significant complications occurring during surgery
- Patients classified as rapid progressors with high IOP despite multiple medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30150270
Actively Recruiting
Research Team
D
Daniel F Moura, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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