Clinical performance of Compass in the diagnosis of glaucoma
| ISRCTN | ISRCTN13800424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13800424 |
| Secondary identifying numbers | CMP_002 |
- Submission date
- 31/07/2015
- Registration date
- 20/08/2015
- Last edited
- 12/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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 reproducibility of the test results, detection and staging (i.e. assessing how severe it is) of glaucoma, and 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?
No specific benefits for participants are expected. 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).
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 July 2017
Who is funding the study?
CenterVue Spa (Italy)
Who is the main contact?
Miss Chiara Rui
Contact information
Public
Via San Marco 9H
Padova
35129
Italy
Study information
| Study design | Observational multicentric cross sectional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical performance of Compass in the diagnosis of glaucoma: a comparison with Humphrey HFA. |
| 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(s) | International Ethics Committee of Milan, Zone A, 22/07/2015, ref: Prot. n° 0019459 |
| 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 | Other |
| Primary outcome measure | 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 study start date | 14/09/2014 |
| Overall study end date | 31/07/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | at least 1200 patients |
| Total final enrolment | 1041 |
| 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 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
- England
- Italy
- United Kingdom
- United States of America
Study participating centres
20142
Italy
33100
Italy
EC1V 2PD
United Kingdom
IA 52242
United States of America
Melbourne
Vic 3010
Australia
Italy
00189
Italy
Sponsor information
Industry
Via San Marco, 9H
Padova
35129
Italy
| Website | http://www.centervue.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | 01/09/2020 | Yes | No |
| Results article | 29/09/2022 | 12/09/2023 | Yes | No | |
| Results article | 02/03/2020 | 12/09/2023 | Yes | No |
Editorial Notes
12/09/2023: Publication references added.
01/09/2020: Publication reference and total final enrolment number added.
06/06/2017: The overall trial end date has been updated from 31/12/2016 to 31/07/2017.
