NCT00254605

Brief Summary

The purpose of this study is to determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2005Nov 2028

Study Start

First participant enrolled

November 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
22.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

22.9 years

First QC Date

November 14, 2005

Last Update Submit

May 5, 2025

Conditions

Retinitis Pigmentosa

Keywords

imagingadaptive optics scanning laser ophthalmoscopeoptical coherence tomographyelectroretinography

Outcome Measures

Primary Outcomes (1)

  • Cone spacing

    The current study will assess cone spacing twice at baseline and every 6 months for 30 months. The primary outcome will be measured at 24 months.

    24 months

Secondary Outcomes (1)

  • Visual acuity

    24 months

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inherited retinal degenerations, including retinitis pigmentosa, choroideremia, x-linked retinoschisis and Usher syndrome. We are also studying a small number of patients with age-related macular degeneration.

You may qualify if:

  • Subjects must speak and understand English
  • Subjects must have pupils that dilate to at least 6 millimeters diameter.
  • Subjects must be willing to travel to University of California (UC) Berkeley.
  • Subjects are financially responsible for their travel to the San Francisco area if they are not San Francisco residents.

You may not qualify if:

  • Cataract
  • Irregular corneal astigmatism (keratoconus)
  • Prior refractive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology Retinal Degenerations Clinic, UCSF

San Francisco, California, 94143, United States

RECRUITING

Related Publications (12)

  • Yoon MK, Roorda A, Zhang Y, Nakanishi C, Wong LJ, Zhang Q, Gillum L, Green A, Duncan JL. Adaptive optics scanning laser ophthalmoscopy images in a family with the mitochondrial DNA T8993C mutation. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1838-47. doi: 10.1167/iovs.08-2029. Epub 2008 Nov 7.

    PMID: 18997096RESULT

  • Duncan JL, Zhang Y, Gandhi J, Nakanishi C, Othman M, Branham KE, Swaroop A, Roorda A. High-resolution imaging with adaptive optics in patients with inherited retinal degeneration. Invest Ophthalmol Vis Sci. 2007 Jul;48(7):3283-91. doi: 10.1167/iovs.06-1422.

    PMID: 17591900RESULT

  • Roorda A, Zhang Y, Duncan JL. High-resolution in vivo imaging of the RPE mosaic in eyes with retinal disease. Invest Ophthalmol Vis Sci. 2007 May;48(5):2297-303. doi: 10.1167/iovs.06-1450.

    PMID: 17460294RESULT

  • Zayit-Soudry S, Sippl-Swezey N, Porco TC, Lynch SK, Syed R, Ratnam K, Menghini M, Roorda AJ, Duncan JL. Repeatability of Cone Spacing Measures in Eyes With Inherited Retinal Degenerations. Invest Ophthalmol Vis Sci. 2015 Sep 1;56(10):6179-89. doi: 10.1167/iovs.15-17010.

    PMID: 26416092DERIVED

  • Wang Q, Tuten WS, Lujan BJ, Holland J, Bernstein PS, Schwartz SD, Duncan JL, Roorda A. Adaptive optics microperimetry and OCT images show preserved function and recovery of cone visibility in macular telangiectasia type 2 retinal lesions. Invest Ophthalmol Vis Sci. 2015 Jan 13;56(2):778-86. doi: 10.1167/iovs.14-15576.

    PMID: 25587056DERIVED

  • Menghini M, Lujan BJ, Zayit-Soudry S, Syed R, Porco TC, Bayabo K, Carroll J, Roorda A, Duncan JL. Correlation of outer nuclear layer thickness with cone density values in patients with retinitis pigmentosa and healthy subjects. Invest Ophthalmol Vis Sci. 2014 Dec 16;56(1):372-81. doi: 10.1167/iovs.14-15521.

    PMID: 25515570DERIVED

  • Zayit-Soudry S, Duncan JL, Syed R, Menghini M, Roorda AJ. Cone structure imaged with adaptive optics scanning laser ophthalmoscopy in eyes with nonneovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Nov 15;54(12):7498-509. doi: 10.1167/iovs.13-12433.

    PMID: 24135755DERIVED

  • Ratnam K, Carroll J, Porco TC, Duncan JL, Roorda A. Relationship between foveal cone structure and clinical measures of visual function in patients with inherited retinal degenerations. Invest Ophthalmol Vis Sci. 2013 Aug 28;54(8):5836-47. doi: 10.1167/iovs.13-12557.

    PMID: 23908179DERIVED

  • Syed R, Sundquist SM, Ratnam K, Zayit-Soudry S, Zhang Y, Crawford JB, MacDonald IM, Godara P, Rha J, Carroll J, Roorda A, Stepien KE, Duncan JL. High-resolution images of retinal structure in patients with choroideremia. Invest Ophthalmol Vis Sci. 2013 Feb 1;54(2):950-61. doi: 10.1167/iovs.12-10707.

    PMID: 23299470DERIVED

  • Ratnam K, Vastinsalo H, Roorda A, Sankila EM, Duncan JL. Cone structure in patients with usher syndrome type III and mutations in the Clarin 1 gene. JAMA Ophthalmol. 2013 Jan;131(1):67-74. doi: 10.1001/2013.jamaophthalmol.2.

    PMID: 22964989DERIVED

  • Duncan JL, Ratnam K, Birch DG, Sundquist SM, Lucero AS, Zhang Y, Meltzer M, Smaoui N, Roorda A. Abnormal cone structure in foveal schisis cavities in X-linked retinoschisis from mutations in exon 6 of the RS1 gene. Invest Ophthalmol Vis Sci. 2011 Dec 20;52(13):9614-23. doi: 10.1167/iovs.11-8600.

    PMID: 22110067DERIVED

  • Mkrtchyan M, Lujan BJ, Merino D, Thirkill CE, Roorda A, Duncan JL. Outer retinal structure in patients with acute zonal occult outer retinopathy. Am J Ophthalmol. 2012 Apr;153(4):757-68, 768.e1. doi: 10.1016/j.ajo.2011.09.007. Epub 2011 Nov 20.

    PMID: 22105799DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jacque L. Duncan, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacque L. Duncan, M.D.

CONTACT

415-514-4241jacque.duncan@ucsf.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

November 1, 2005

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations

US(1)