Status:

COMPLETED

Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium

Lead Sponsor:

Carl Zeiss Meditec, Inc.

Collaborating Sponsors:

DataMed Devices Inc.

Conditions:

Advanced Dry AMD With Geographic Atrophy

Eligibility:

All Genders

50+ years

Brief Summary

The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).

Detailed Description

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two pha...

Eligibility Criteria

Inclusion

  • Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
  • Geographic atrophy lesions should:
  • Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
  • Not be smaller than 1.25 mm2.
  • Not be confluent with peri-papillary atrophy.
  • Not be combined with other lesions such as CNV.
  • Able and willing to make the required study visits.
  • Able and willing to give consent and follow study instructions.

Exclusion

  • History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
  • Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
  • Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
  • Concomitant use of hydrochloroquine or chloroquine.
  • Unable to make the required study visits.
  • Unable to give consent or follow study instructions.

Key Trial Info

Start Date :

November 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

85 Patients enrolled

Trial Details

Trial ID

NCT01890187

Start Date

November 1 2010

End Date

February 1 2011

Last Update

July 1 2013

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

West Coast Retina

Walnut Creek, California, United States, 94107