Retinal Imaging in Patients With Inherited Retinal Degenerations
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| ClinicalTrials.gov Identifier: NCT00254605 |
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Recruitment Status :
Recruiting
First Posted : November 16, 2005
Last Update Posted : October 6, 2022
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| Condition or disease |
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| Retinitis Pigmentosa |
Retinal degenerations are a group of inherited diseases that result in progressive death of the vision cells, or photoreceptors. Currently there is no treatment or cure for any of these diseases and they ultimately cause blindness in affected patients. We propose to investigate the structure and function of the human retina in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO). We will correlate the images of retinal structure produced by the AOSLO with Optical Coherence Tomography (OCT) images of the retina. In addition, we will study the vision of individual photoreceptors using the AOSLO to perform a novel technique, microperimetry, in patients with retinal degenerations. We will compare the results of microperimetry with standard measures of vision used in Ophthalmology clinics, including visual acuity, automated perimetry, fundus photography and multifocal electroretinography (mfERG).
The results of this work will provide insight into the mechanism of vision loss among patients with diverse retinal disorders. Specifically, we will study cone structure and function in patients with retinal degenerations with different etiologies: retinitis pigmentosa, a disease usually caused by rod-specific mutations; cone-rod dystrophy, which primarily affects cones rather than rods; and Best's disease, a disease caused by a defect in the retinal pigment epithelium (RPE). In addition, we will study the effect that lipofuscin, a byproduct of photoreceptor metabolism that accumulates in the RPE in diseases such as Stargardt's disease, Best's disease and age-related macular degeneration (AMD), has on cone structure and function, with the goal of understanding how these diseases cause blindness. Better understanding of the mechanisms of vision loss in patients with retinal degeneration should ultimately lead to treatments for these blinding conditions.
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | High Resolution Retinal Imaging in Patients With Inherited Retinal Degenerations |
| Study Start Date : | November 2005 |
| Estimated Primary Completion Date : | October 2023 |
| Estimated Study Completion Date : | November 2024 |
- Cone spacing [ Time Frame: 24 months ]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.
- Visual acuity [ Time Frame: 24 months ]Visual acuity will be measured every 6 months for 30 months with the primary outcome measure at 24 months.
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cataract
- Irregular corneal astigmatism (keratoconus)
- Prior refractive surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254605
| Contact: Jacque L. Duncan, M.D. | 415-514-4241 | jacque.duncan@ucsf.edu | |
| Contact: Arshia Mian, B.S. | 415-476-0444 | arshia.mian@ucsf.edu |
| United States, California | |
| Department of Ophthalmology Retinal Degenerations Clinic, UCSF | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Arshia Mian, B.S. 415-476-0444 arshia.mian@ucsf.edu | |
| Contact: Jacque Duncan, MD 415-514-4241 jacque.duncan@ucsf.edu | |
| Principal Investigator: | Jacque L. Duncan, M.D. | University of California, San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00254605 |
| Other Study ID Numbers: |
H12225-27221-0+1 |
| First Posted: | November 16, 2005 Key Record Dates |
| Last Update Posted: | October 6, 2022 |
| Last Verified: | October 2022 |
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imaging adaptive optics scanning laser ophthalmoscope optical coherence tomography electroretinography |
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Retinitis Retinitis Pigmentosa Retinal Degeneration Retinal Diseases |
Eye Diseases Eye Diseases, Hereditary Retinal Dystrophies Genetic Diseases, Inborn |