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Trial Outcomes & Findings for Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO (NCT NCT01692938)

NCT ID: NCT01692938

Last Updated: 2017-05-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

1 Month

Results posted on

2017-05-10

Participant Flow

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

Participant milestones

Participant milestones
Measure
No Retinal Disease
Retinal Disease
Overall Study
STARTED
16
16
Overall Study
COMPLETED
12
12
Overall Study
NOT COMPLETED
4
4

Reasons for withdrawal

Reasons for withdrawal
Measure
No Retinal Disease
Retinal Disease
Overall Study
Protocol Deviation
1
1
Overall Study
Study completed prior to site completion
3
3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
No Retinal Disease
n=12 Participants
Retinal Disease
n=12 Participants
Total
n=24 Participants
Total of all reporting groups
Age, Customized
21-35 years
4 participants
n=5 Participants
3 participants
n=7 Participants
7 participants
n=5 Participants
Age, Customized
36-50 years
4 participants
n=5 Participants
3 participants
n=7 Participants
7 participants
n=5 Participants
Age, Customized
51-64 years
3 participants
n=5 Participants
3 participants
n=7 Participants
6 participants
n=5 Participants
Age, Customized
65 years or great
1 participants
n=5 Participants
3 participants
n=7 Participants
4 participants
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
No Retinal Disease
n=12 Participants
Retinal Disease
n=12 Participants
Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
16.16 decibels
Standard Deviation 1.735
12.23 decibels
Standard Deviation 3.508

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
No Retinal Disease
n=12 Participants
Retinal Disease
n=12 Participants
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.
Repeatability SD
16.16 decibels
Standard Deviation 0.531
12.23 decibels
Standard Deviation 0.682
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.
Repeatability SD Limit
16.16 decibels
Standard Deviation 1.49
12.23 decibels
Standard Deviation 1.91

Adverse Events

No Retinal Disease

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Retinal Disease

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Quan Nguyen, MD Director of the Stanley M. Truhlsen Eye Institute

Stanley M. Truhlsen Eye Institute

Phone: 402-559-4276

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60