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Completed

NCT Number: NCT03626207

Development of Visual Function Evaluation Method (2)

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

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site JP00001

Kobe, Hyōgo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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