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Development of Visual Function Evaluation Method

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ClinicalTrials.gov Identifier: NCT03281005
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient

Condition or disease
Retinitis Pigmentosa

Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Group/Cohort
Retinitis pigmentosa
Retinitis pigmentosa patients with severe visual impairment



Primary Outcome Measures :
  1. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Up to week 8 ]
    To assess the visual function and the quality of life (QOL)

  2. The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) [ Time Frame: Up to week 8 ]
    To assess the visual function and the quality of life (QOL)

  3. Nottingham Adjustment Scale Japanese Version (NAS-J) [ Time Frame: Up to week 8 ]
    To assess the psychological adjustment

  4. Daily living task dependent on vision (DLTV) [ Time Frame: Up to week 8 ]
    To assess the quality of life (QOL)

  5. Table test [ Time Frame: Up to week 8 ]
    To assess the visual function

  6. Low vision evaluator (LoVE) [ Time Frame: Up to week 8 ]
    To assess the visual function

  7. Metropsis test [ Time Frame: Up to week 8 ]
    To assess the visual function

  8. Color flash visual evoked potential (VEP) test [ Time Frame: Up to week 8 ]
    To assess the visual function

  9. Electrically evoked response (EER) test [ Time Frame: Up to week 8 ]
    To assess the visual function

  10. Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Up to week 8 ]
    To assess the visual function

  11. Optical Coherence Tomography (OCT) test [ Time Frame: Up to week 8 ]
    To assess the visual function

  12. White flash VEP test [ Time Frame: Up to week 8 ]
    To assess the visual function

  13. White flash Electroretinography test [ Time Frame: Up to week 8 ]
    To assess the visual function



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retinitis pigmentosa
Criteria

Inclusion Criteria:

  • Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent

Exclusion Criteria:

  • Patients should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
  • History of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
  • Pregnant women

Information from the National Library of Medicine

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): NCT03281005


Contacts
Contact: Clinical Development Administration Dept. astellas.registration@astellas.com

Locations
Japan
Site JP00001 Recruiting
Meguro, Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03281005     History of Changes
Other Study ID Numbers: CRE170041
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:
Retinitis pigmentosa
Visual function evaluation

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn