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Clinical performance of Compass in the diagnosis of glaucoma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13800424
Enrollment
1200
Registered
2015-08-20
Start date
2015-09-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye Diseases Glaucoma

Interventions

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 und

Sponsors

CenterVue SpA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Normal subjects: 1. Age: 18 - 90 years old 2. best corrected visual acuity > 0.8 (if 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 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

Exclusion criteria: Normal subjects: 1. Age: 90 years old 2. Best corrected visual acuity 50 years old) in study eye 3. Refraction +6D; astigmatism between 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: 90 years old 2. Best corrected visual acuity 50 years old) in study eye 3. Refraction +6D; astigmatism between 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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Australia, England, Italy, United Kingdom, United States of America

Contacts

Public ContactChiara Rui

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026