Trial Outcomes & Findings for Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE) (NCT NCT01272076)
NCT ID: NCT01272076
Last Updated: 2014-01-20
Results Overview
In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.
COMPLETED
85 participants
August 2011
2014-01-20
Participant Flow
85 subjects were enrolled between 1/10/2011 - 2/25/2011. The study was conducted at Retina Specialist clinics.
After enrollment a screening image of the retina is done to ensure that the area of Geographic Atrophy is consistent with the inclusion criteria. We enrolled 85 subjects, however, 19 were determined not to be eligible per study protocol. In addition, images of 14 subjects did not meet predetermined qualification criteria per study protocol.
Participant milestones
| Measure |
Dry AMD With Geographic Atrophy
Patients diagnosed with dry AMD and geographic atrophy
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Baseline characteristics by cohort
| Measure |
GA Group
n=52 Participants
Patients diagnosed with dry AMD and geographic atrophy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
83.6 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: August 2011Population: Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.
In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.
Outcome measures
| Measure |
GA Group
n=52 Participants
Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
|
|---|---|
|
Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).
|
0.1 mm^2
Standard Deviation 1.9
|
Adverse Events
GA Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 until the device is released on the market.
- Publication restrictions are in place
Restriction type: OTHER