Clinical Study of the Optic Disc Parameters

• Sponsor: Topcon Medical Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02277119
• Collaborator: (none)
• Enrollment: 109
• Locations: 2
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 54.5
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Condition or Disease	Intervention/Treatment	Phase
Normal Healthy Subjects With No Known Ocular Diseases; Glaucomatous Eyes; Eyes With Retinal Diseases	Device: Maestro; Device: iVue	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal Eyes Subjects with no known ocular diseases will be scanned with the iVue and Maestro device	Device: Maestro; OCT machines used for diagnostic purposes; Device: iVue; OCT machines used for diagnostic purposes
Experimental: Glaucomatous Eyes Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device	Device: Maestro; OCT machines used for diagnostic purposes; Device: iVue; OCT machines used for diagnostic purposes
Experimental: Eyes with Retinal Diseases Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device	Device: Maestro; OCT machines used for diagnostic purposes; Device: iVue; OCT machines used for diagnostic purposes

Outcome Measures

Primary Outcome Measures

1. Optic Disc Measurements (Optic Disc Size) [1 Hour]

   Reporting of the Optic Disc Size difference between the Maestro and iVue

2. Retinal Nerve Fiber Layer (RNFL) Thickness Measurements [1 Hour]

   RNFL thickness measured

3. Full Retinal Thickness Measurement [1 Hour]

   Full Retinal Thicknesses Measurement

4. Optic Disc Measurement (Cup Size) [1 Hour]

   Reporting of the Cup size difference between the Maestro and iVue

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria for Normal Group

1. Subjects 18 years of age or older on the date of informed consent

2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

3. Subjects presenting at the site with normal eyes (eyes without pathology)

4. lOPs 21mmHg bilaterally

5. BCVA 20/40 or better (each eye)

6. Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

2. Subjects unable to tolerate ophthalmic imaging

3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

4. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%

5. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses> 33% or false positives > 25%, or false negatives > 25%

6. Presence of any ocular pathology except for cataract

7. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning

8. Narrow angle

9. History of leukemia, dementia or multiple sclerosis

10. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Glaucoma Group

1. Subjects 18 years of age or older on the date of informed consent

2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

3. Subjects presenting at the site with glaucoma

4. BCVA 20/40 or better in the study eye

5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5% in the study eye

Exclusion Criteria for Glaucoma Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

2. Subjects unable to tolerate ophthalmic imaging

3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

4. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study eye

5. Presence of any ocular pathology except glaucoma in the study eye

6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye

7. History of leukemia, dementia or multiple sclerosis

8. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retinal Group

1. Subjects 18 years of age or older on the date of informed consent

2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

3. Subjects presenting at the site with retinal disease

4. lOP <= 21mmHg in the study eye

5. BCVA 20/400 or better in the study eye

6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others

Exclusion Criteria for Retinal Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.

2. Subjects unable to tolerate ophthalmic imaging

3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images

4. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye

5. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning in the study eye

6. Narrow angle in the study eye

7. History of leukemia, dementia or multiple sclerosis

8. Concomitant use of hydroxychloroquine and chloroquine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western University of Health Sciences	Pomona	California	United States	91716
2	SUNY College of Optometry	New York	New York	United States	10036

Sponsors and Collaborators

• Topcon Medical Systems, Inc.

Investigators

• Study Director: Mike Sinai, PhD, Topcon Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT02277119
• Other Study ID Numbers: Maestro2
• First Posted: Oct 28, 2014
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Retinal Diseases

Study Results

Participant Flow

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
Period Title: Overall Study
STARTED	58	24	27
COMPLETED	55	20	19
NOT COMPLETED	3	4	8

Baseline Characteristics

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases	Total
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Total of all reporting groups
Overall Participants	58	24	27	109
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	55 94.8%	16 66.7%	19 70.4%	90 82.6%
>=65 years	3 5.2%	8 33.3%	8 29.6%	19 17.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.2 (13.3)	57.8 (20.2)	60.5 (13.4)	48.7 (18.1)
Sex: Female, Male (Count of Participants)
Female	32 55.2%	10 41.7%	13 48.1%	55 50.5%
Male	26 44.8%	14 58.3%	14 51.9%	54 49.5%
Region of Enrollment (participants) [Number]
United States	58 100%	24 100%	27 100%	109 100%
Optic Disc Area Difference (Microns Squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Microns Squared]	0.197 (0.228)	0.201 (0.262)	0.097 (0.216)	0.165 (0.235)

Outcome Measures

1. Primary Outcome

Title	Optic Disc Measurements (Optic Disc Size)
Description	Reporting of the Optic Disc Size difference between the Maestro and iVue
Time Frame	1 Hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
Measure Participants	58	24	27
Mean (Standard Deviation) [Mircrons squared]	0.197 (.228)	0.097 (0.216)	0.201 (0.262)

2. Primary Outcome

Title	Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
Description	RNFL thickness measured
Time Frame	1 Hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
Measure Participants	58	24	27
Mean (Standard Deviation) [Microns]	4.682 (4.333)	2.526 (6.367)	4.103 (8.789)

3. Primary Outcome

Title	Full Retinal Thickness Measurement
Description	Full Retinal Thicknesses Measurement
Time Frame	1 Hour

Outcome Measure Data

Analysis Population Description

Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
Measure Participants	19	0	18
Mean (Standard Deviation) [Microns]	22.845 (11.482)	21.299 (24.524)

4. Primary Outcome

Title	Optic Disc Measurement (Cup Size)
Description	Reporting of the Cup size difference between the Maestro and iVue
Time Frame	1 Hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Eyes	Glaucomatous Eyes	Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
Measure Participants	58	24	27
Mean (Standard Deviation) [Microns cubed]	0 (0.072)	-0.003 (0.124)	0.016 (0.065)

Adverse Events

Arm/Group Title	Normal Eyes		Glaucomatous Eyes		Eyes With Retinal Diseases
Arm/Group Description	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes		Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes		Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes
All Cause Mortality
	Normal Eyes		Glaucomatous Eyes		Eyes With Retinal Diseases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Normal Eyes		Glaucomatous Eyes		Eyes With Retinal Diseases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/24 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Normal Eyes		Glaucomatous Eyes		Eyes With Retinal Diseases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/24 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.