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Trial record 2 of 42 for:    Recruiting, Not yet recruiting, Enrolling by invitation Studies | Astellas [Lead]

Development of Visual Function Evaluation Method (2)

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ClinicalTrials.gov Identifier: NCT03626207
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : October 18, 2018
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 : 8 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 : October 4, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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



Primary Outcome Measures :
  1. Slit-lamp-microscopy [ Time Frame: Up to 3 months ]
    To assess the visual function.

  2. Optical Coherence Tomography (OCT) test [ Time Frame: Day 1 ]
    To assess the visual function.

  3. Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Up to 3 months ]
    To assess the visual function.

  4. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Up to 3 months ]
    NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

  5. The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) [ Time Frame: Up to 3 months ]
    NEI VFQ 11 is a questionnaire intended to measure visual function and quality of life. It has 11 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

  6. Nottingham Adjustment Scale Japanese Version (NAS-J) [ Time Frame: Up to 3 months ]
    NAS-J is the Japanese version of NAS which measures psychological adjustment to the visual impairment, and to assess its validity and reliability. The NAS is composed of 7 psychological subscales including anxiety-depression, self-esteem, attitude to disability, locus of control, acceptance of disability, self-efficacy and attributional style. The original response of each item are coded as per the NAS-J scoring system ranging from 0 (lowest psychological adjustment) to 100 (highest psychological adjustment).

  7. Daily living task dependent on vision (DLTV) questionnaire [ Time Frame: Up to 3 months ]
    DLTV is a quality of life questionnaire composed of 22 items to obtain estimates of self-reported ability to perform vision-related tasks in persons with visual impairment. Participants rate items on a four-point scale, with "Can't see to do" (score, 1), "A lot of difficulty" (score, 2), "A little difficulty" (score, 3), and"No difficulty" (score, 4). The original response of each item are coded as per the DLTV scoring system ranging from 0 (worst) to 100 (best).

  8. Table test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  9. Monitor test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  10. Pupillary function test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  11. Full field stimulus threshold testing (FST) [ Time Frame: Up to 3 months ]
    To assess the visual function.

  12. White flash visual evoked potential (VEP) test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  13. Color flash VEP test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  14. Electrically evoked response (EER) test [ Time Frame: Up to 3 months ]
    To assess the visual function.

  15. White flash Electroretinography (ERG) test [ Time Frame: Day 1 ]
    To assess the visual function.

  16. Multifocal ERG test [ Time Frame: Up to 3 months ]
    To assess the visual function.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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 and at screening

Exclusion Criteria:

  • Subjects 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
  • Subjects who are judged that continuation of the study is difficult during the study period
  • Subjects who are employed by the company sponsoring this study, an organization or institution related to this study

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): NCT03626207


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

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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03626207     History of Changes
Other Study ID Numbers: CLR180001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual patient level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Information for Astellas."

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