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Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression

C

Centervue

Status

Enrolling

Conditions

Glaucoma

Study type

Observational

Funder types

Industry

Identifiers

NCT05801471
CMP_005

Details and patient eligibility

About

The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.

Enrollment

200 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

2

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Central trial contact

Chiara Rui

Data sourced from clinicaltrials.gov

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