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

Glaucoma Clinical Trial

Official title:

An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801471
• Other study ID #: CMP_005
• Status: Recruiting
• Start date: May 6, 2022
• Est. completion date: November 6, 2025

Study information

• Verified date: April 2023
• Source: Centervue SpA
• Contact: Chiara Rui
• Phone: +39 049 501 8399
• Email: chiara.rui[@]icare-world.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 6, 2025
• Est. primary completion date: November 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Italy	Clinica oculistica Ospedale San Paolo	Milano
Italy	Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti"	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Centervue SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).	Equivalence will be defined as the 95% confidence Intervals of the mean difference between the slopes estimated with the two devices being within ± 0.1 dB/year	1 visit every 4 months (10 visits total), up to 3 years
Secondary	Difference in time to identify progression between Compass and HFA using an event analysis	Time of first detectable change [years]	1 visit every 4 months (10 visits total), up to 3 years
Secondary	Quantification of the effect of the integration of the rate of progression of structural metrics into the calculation of the rate of progression of the MD	Quantification of the effect of the integration of the rate of progression of structural metrics (mainly the retinal nerve fiber layer thickness, microns/year) into the calculation of the rate of progression of the MD. This effect will be quantified as the improvement in the equivalence metric defined for Outcome 1; The integration of structural OCT RNFL thickness information into progression analysis will be done using a Bayesian Linear Regression approach as suggested by Russel at al.[*]; [*] R.A. Russel at al.; "Improved Estimates of Visual Field Progression Using Bayesian Linear Regression to Integrate Structural Information in Patients with Ocular Hypertension"; IOVS May 2012; 53(6): 2760-2769.	1 visit every 4 months (10 visits total), up to 3 years