Clinical performance of Compass in the diagnosis of glaucoma

Not Applicable

Completed

• Conditions: Glaucoma; Eye Diseases

• Registration Number: ISRCTN13800424
• Lead Sponsor: CenterVue SpA

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30114416/ results (added 01/09/2020) 2022 Results article in https://doi.org/10.3389/fmed.2022.923096 (added 12/09/2023) 2020 Results article in http://dx.doi.org/10.1136/bjophthalmol-2019-315070 (added 12/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-20
• Study Completion: 2017-07-31
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1041

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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