Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO

• Sponsor: Optos, PLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01692938
• Collaborator: Johns Hopkins University (Other), University of Southern California (Other)
• Enrollment: 32
• Locations: 3
• Duration (Months): 1
• Patients Per Site: 10.7
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration; Geographic Atrophy; Diabetic Retinopathy; Macular Edema; Retinal Vein Occlusion; Central Serous Retinopathy; Pattern Dystrophy of Macula; Epiretinal Membrane; Macular Hole

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Retinal Disease
Retinal Disease

Outcome Measures

Primary Outcome Measures

1. Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations [1 Month]

   A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.

2. Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination. [1 Month]

   A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject must be 21 years of age or older.

• Subjects recruited to Cohort 1 will have no known retinal disease except for refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2 will have one or more of the following retinal pathologies: early and intermediate Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild, moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole.

• Subjects who have signed an informed consent form.

• Subjects who can comply with the protocol.

Exclusion Criteria:

• Subjects younger than 21 years of age.

• Subjects who cannot comply with the protocol.

• Subjects who cannot complete the Simple Test procedures

• Subjects who are not available to be testing 3 times during the day (Morning, Mid - Day, and Afternoon).

• Subjects with visual acuity worse than 20/100 (Best Corrected).

• Subjects with dense media opacities.

• Ocular surgery anticipated on the day of the study visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Group of Florida	Fort Lauderdale	Florida	United States	33334
2	Johns Hopkins Unversity	Baltimore	Maryland	United States	21287
3	Valley Retina Institute	McAllen	Texas	United States	78503

Sponsors and Collaborators

• Optos, PLC
• Johns Hopkins University
• University of Southern California

Investigators

• Principal Investigator: Quan Nguyen, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Optos, PLC
• ClinicalTrials.gov Identifier: NCT01692938
• Other Study ID Numbers: OPT1001
• First Posted: Sep 26, 2012
• Last Update Posted: May 10, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Macular Degeneration; Macular Edema; Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion; Retinal Perforations; Geographic Atrophy; Epiretinal Membrane; Central Serous Chorioretinopathy

Study Results

Participant Flow

Recruitment Details	Recruitment Dates - 10/5/2012 to 11/5/2012. 3 Ophthalmic Clinics.

Arm/Group Title	No Retinal Disease	Retinal Disease
Arm/Group Description
Period Title: Overall Study
STARTED	16	16
COMPLETED	12	12
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	No Retinal Disease	Retinal Disease	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	12	12	24
Age, Customized (participants) [Number]
21-35 years	4 33.3%	3 25%	7 29.2%
36-50 years	4 33.3%	3 25%	7 29.2%
51-64 years	3 25%	3 25%	6 25%
65 years or great	1 8.3%	3 25%	4 16.7%
Sex: Female, Male (Count of Participants)
Female	8 66.7%	6 50%	14 58.3%
Male	4 33.3%	6 50%	10 41.7%

Outcome Measures

1. Primary Outcome

Title	Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
Description	A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Retinal Disease	Retinal Disease
Arm/Group Description
Measure Participants	12	12
Mean (Standard Deviation) [decibels]	16.16 (1.735)	12.23 (3.508)

2. Primary Outcome

Title	Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.
Description	A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Retinal Disease	Retinal Disease
Arm/Group Description
Measure Participants	12	12
Repeatability SD	16.16 (0.531)	12.23 (0.682)
Repeatability SD Limit	16.16 (1.49)	12.23 (1.91)

Adverse Events

Arm/Group Title	No Retinal Disease		Retinal Disease
Arm/Group Description
All Cause Mortality
	No Retinal Disease		Retinal Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	No Retinal Disease		Retinal Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	No Retinal Disease		Retinal Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.