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Register:	ISRCTN
Last refreshed on:	26 September 2023
Main ID:	ISRCTN13800424
Date of registration:	20/08/2015
Prospective Registration:	Yes
Primary sponsor:	CenterVue SpA
Public title:	Clinical performance of Compass in the diagnosis of glaucoma
Scientific title:	Clinical performance of Compass in the diagnosis of glaucoma: a comparison with Humphrey HFA.
Date of first enrolment:	01/09/2015
Target sample size:	1200
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN13800424
Study type:	Observational
Study design:	Observational multicentric cross sectional trial (Diagnostic)
Phase:	Not Applicable

Countries of recruitment
Australia	England	Italy	United Kingdom	United States of America

Contacts

Name:	Chiara Rui
Address:	Via San Marco 9H 35129 Padova Italy
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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)

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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma
Eye Diseases
Glaucoma

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CMP_002

Source(s) of Monetary Support

CenterVue Spa (Italy)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; International Ethics Committee of Milan, Zone A, 22/07/2015, ref: Prot. n° 0019459

Results

Results available:	Yes
Date Posted:
Date Completed:	31/07/2017
URL:

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