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Completed

NCT Number: NCT03281005

Development of Visual Function Evaluation Method

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

Meguro-ku, Tokyo, Japan

About this study

This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for patients with retinitis pigmentosa:

  • Age: ≥ 20 years
  • Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent

Inclusion criteria

for healthy Volunteers:

  • Age: ≥ 35 and ≤ 75 years
  • Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening

Exclusion criteria

  • Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
  • Subjects who have 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 in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  2. Slit-lamp microscopy in Part 1B and 3

    Time frame: Day 1

    To assess the visual function

  3. Optical Coherence Tomography (OCT) test in Part 1A and 2

    Time frame: Day 1

    To assess the visual function

  4. Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  5. Visual acuity test with ETDRS in Part 1B

    Time frame: Day 1

    To assess the visual function

  6. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function and the quality of life (QOL)

  7. The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function and QOL

  8. Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2

    Time frame: Up to week 8

    To assess the psychological adjustment

  9. Daily living task dependent on vision (DLTV) in Part 1A and 2

    Time frame: Up to week 8

    To assess QOL

  10. Table test in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  11. Metropsis test in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  12. Low vision evaluator (LoVE) in Part 1A

    Time frame: Up to week 8

    To assess the visual function

  13. White flash visual evoked potential (VEP) test in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  14. White flash VEP test in Part 1B and 3

    Time frame: Day 1

    To assess the visual function

  15. Color flash VEP test in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  16. Color flash VEP test in Part 1B and 3

    Time frame: Day 1

    To assess the visual function

  17. Electrically evoked response (EER) test in Part 1A and 2

    Time frame: Up to week 8

    To assess the visual function

  18. EER test in Part 1B and 3

    Time frame: Day 1

    To assess the visual function

  19. White flash electroretinography test in Part 1A, 1B, 2 and 3

    Time frame: Day 1

    To assess the visual function

  20. Pupillary function test in Part 2

    Time frame: Up to week 8

    To assess the visual function

  21. Pupillary function test in Part 1B and 3

    Time frame: Day 1

    To assess the visual function

  22. Full field stimulus threshold testing (FST) in Part 2

    Time frame: Up to week 8

    To assess the visual function

  23. FST in Part 1B

    Time frame: Day 1

    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
2017
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2017
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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