Evaluating visual field changes in glaucoma patients
An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression
Centervue SpA · NCT05801471
This study is trying to see how different ways of measuring vision changes can help track the progression of glaucoma in patients over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Centervue SpA (industry) |
| Locations | 2 sites (Milan, Milano and 1 other locations) |
| Trial ID | NCT05801471 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data over a 36-month period from patients with glaucoma to assess various methods for defining the progression of the disease. Participants will undergo repeated visits where their retinal functionality will be evaluated using the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA). Additionally, Optical Coherence Tomography (OCT) will be performed to gather clinical information about the retinal structure. The study focuses on understanding how different models can effectively track changes in visual fields associated with glaucoma.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 90 with glaucomatous optic nerve head in both eyes and specific visual acuity and refraction criteria.
Not a fit: Patients with advanced glaucoma or other ocular conditions that could affect visual field assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring glaucoma progression, enhancing patient management and treatment outcomes.
How similar studies have performed: While similar observational studies have been conducted, this specific approach to evaluating visual field progression in glaucoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Glaucomatous optic nerve head in both eyes; * Age between 40 and 90 years; * Best Corrected Visual Acuity ≤ 0.3 \[logMar\]; * Spherical refraction between -6D and +6D; * Astigmatism between -2D and +2D. Exclusion Criteria: * Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment; * Any ocular pathology that can affect visual field other than glaucoma; * Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss; * Inability to obtain reliable perimetric examinations; * Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
Where this trial is running
Milan, Milano and 1 other locations
- Clinica oculistica Ospedale San Paolo — Milan, Milano, Italy (RECRUITING)
- Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti" — Roma, Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Luca M. Rossetti, Prof. — Clinica oculistica Ospedale San Paolo
- Study coordinator: Chiara Rui
- Email: chiara.rui@icare-world.com
- Phone: +39 049 501 8399
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.
Conditions: Glaucoma