Condition category
Eye Diseases
Date applied
31/07/2015
Date assigned
20/08/2015
Last edited
20/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Glaucoma is an eye condition which develops when a fluid inside the eye (called aqueous humour) cannot drain properly, causing pressure to build up that can result in damage to the optic nerve and nerve fibres from the retina. It often affects both eyes, generally with one being more affected than the other, and, over time, it can lead to a partial or complete loss of sight. The purpose of this study is to test the diagnostic performance of COMPASS, a new device for assessing the degree of glaucoma in comparison with the Humphrey HFA-II perimeter, which is the recognized clinical "gold standard". In particular this study is aimed at comparing:
1. Reproducibility of the test results
2. Detection and staging (i.e. assessing how severe it is) of glaucoma
3. How long the test takes
The study also aims to obtain reference values from a group of healthy people without glaucoma.

Who can participate?
Healthy volunteers and glaucoma patients aged 18-90.

What does the study involve?
All participants have a complete ophthalmological evaluation to see whether they are eligible to take part. Participants that are eligible either has one perimetric test in both eyes with the Humphrey and COMPASS or a total of 6 tests with the two perimeters to assess test-retest variability (i.e. to see whether the test comes up with a similar result every time).

What are the possible benefits and risks of participating?
There are no known risks associated with taking part in the study. No adverse events have been reported from a previous study with the Compass device except for lacrimation (eye watering).
No specific benefits for participants are expected.

Where is the study run from?
1.Ophthalmology Hospital San Paolo in Milan (Italy),
2.Hospital Santa Maria della Misericordia in Udine (Italy)
3.Moorfields Eye Hospital, London (UK)
4.University of Iowa, Carver College of Medicine (USA)
5.University of Melbourne Eyecare, Department of Optometry & Vision Sciences (Australia)
6.IRCCS - Foundation "Bietti GB" for the Study and Research in Ophthalmology ONLUS (Italy)
7.Ophthalmology Clinic of the Sant'Andrea Hospital of Rome (Italy)

When is the study starting and how long is it expected to run for?
September 2015 to June 2016

Who is funding the study?
CenterVue Spa (Italy)

Who is the main contact?
Miss Chiara Rui

Trial website

Contact information

Type

Public

Primary contact

Miss Chiara Rui

ORCID ID

Contact details

Via San Marco 9H
Padova
35129
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CMP_002

Study information

Scientific title

Clinical performance of Compass in the diagnosis of glaucoma: a comparison with Humphrey HFA.

Acronym

Study hypothesis

The aim of the study is to evaluate the diagnostic performance of a new perimeter (the "Compass") and compare it to the Humphrey HFA on a population of normal subjects and glaucomatous patients in order to:
1. Compare test-retest variability
2. Compare clinically performance in staging glaucoma
3. Compare test time

Ethics approval

International Ethics Committee of Milan, Zone A, 22/07/2015, ref: Prot. n° 0019459

Study design

Observational multicentric trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Glaucoma

Intervention

This cross-sectional, observational, multi-centric study involves acquisition of visual field tests from both normal and glaucomatous subjects using two different perimeters. Each patient enrolled undergoes a full ophthalmological evaluation and perimetric tests on both eyes or on one randomly selected eye, depending on study arm. One arm is aimed at assessing test-retest variability, the other one at comparing visual field values of both perimeters. Both arms include healthy and glaucomatous subjects.

Intervention type

Phase

Drug names

Primary outcome measures

Test-retest variability, assessed by parametric statistical methods, on both normal subjects and subjects with glaucoma.

Secondary outcome measures

1. Sensitivity / specificity of the diagnosis of glaucoma using both perimeters vs. diagnosis from a glaucoma expert using independent data (morphological and functional data)
2. Average test time
3. Age-matched normative database

Overall trial start date

14/09/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Normal subjects:
1. Age: 18 - 90 years old
2. best corrected visual acuity > 0.8 (if <50 years old) or >6/10 (if >50 years old) in study eye
3. Refraction -10D / +6D; astigmatism between - 2D and 2D
4. Normal optic nerve head in both eyes (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning);
5. IOP less than 21 mmHg in both eyes
6. No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
7. Absence of pathologies that can affect visual field
8. No use of drugs interfering with the correct execution of perimetry
9. Should have at least two reliable VF exams (for example one HFA, one Compass)

Glaucoma patients:
1. Age: 18 - 90 years old
2. Best corrected visual acuity > 0.8 (if <50 years old) or >6/10 (if >50 years old) in study eye;
3. Refraction -10D / +6D; astigmatism between - 2D and 2D
4. Glaucomatous optic nerve head in both eyes (according to the specialist opinion at ophthalmoscopy) and abnormal OCT (ONH and RNFL)
5. Patients under anti-glaucoma therapy
6. No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
7. Absence of pathologies that can affect visual field other than glaucoma
8. No use of drugs interfering with the correct execution of perimetry or that would produce visual field loss
9. Should have at least two reliable VF exams (for example one HFA, one Compass)

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

at least 1200 patients

Participant exclusion criteria

Normal subjects:
1. Age: <18 or >90 years old
2. Best corrected visual acuity <= 0.8 (if <50 years old) or <=6/10 (if >50 years old) in study eye
3. Refraction < -10D or >+6D; astigmatism between <- 2D or >2D
4. Abnormal optic nerve head in both eyes ( evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning)
5. IOP > 21 mmHg in both eyes
6. Ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
7. Presence of pathologies that can affect visual field
8. Use of drugs interfering with the correct execution of perimetry
9. Less than two reliable VF exams

Glaucomatous subjects:
1. Age: <18 or >90 years old
2. Best corrected visual acuity <= 0.8 (if <50 years old) or <=6/10 (if >50 years old) in study eye
3. Refraction < -10D or >+6D; astigmatism between <- 2D or >2D
4. Normal optic nerve head in both eyes (according to the specialist opinion at ophthalmoscopy) and normal OCT (ONH and RNFL)
5. Patient not under anti-glaucoma therapy
6. Ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
7. Presence of pathologies that can affect visual field other than glaucoma
8. Use of drugs interfering with the correct execution of perimetry or that would produce visual field loss
9. Less than two reliable VF exams (for example one HFA, one Compass)

Recruitment start date

01/09/2015

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Australia, Italy, United Kingdom, United States of America

Trial participating centre

Ophthalmology Hospital San Paolo in Milan
Milan
20142
Italy

Trial participating centre

Hospital Santa Maria della Misericordia in Udine
Udine
33100
Italy

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Trial participating centre

University of Iowa, Carver College of Medicine
Iowa
IA 52242
United States of America

Trial participating centre

University of Melbourne Eyecare
Department of Optometry & Vision Sciences
Melbourne
Vic 3010
Australia

Trial participating centre

IRCCS - Foundation "Bietti GB" for the Study and Research in Ophthalmology ONLUS
00198
Italy

Trial participating centre

Ophthalmology Clinic of the Sant'Andrea Hospital of Rome
Rome
00189
Italy

Sponsor information

Organisation

CenterVue SpA

Sponsor details

Via San Marco
9H
Padova
35129
Italy

Sponsor type

Industry

Website

http://www.centervue.com

Funders

Funder type

Industry

Funder name

CenterVue Spa (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes